Siemens Healthcare Diagnostics, Inc. - Atellica CH Creatine Kinase (CK_L) - Class 2 Recall
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - ADVIA Chemistry Creatine Kinase (CK_L) - Class 2 Recall
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

OATMEAL (Dimethicone) Lotion [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD]
Updated Date: Jun 26, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 26, 2019 Category: Drugs & Pharmacology Source Type: alerts

HAND SANITIZER ANTIBACTERIAL WITH MOISTURIZERS AND ALOE 8OZ (Alcohol) Gel [Ningbo Liyuan Daily Chemical Products Co.,Ltd.]
Updated Date: Jun 24, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2019 Category: Drugs & Pharmacology Source Type: alerts

HAND SANITIZER ANTIBACTERIAL WITH MOISTURIZERS AND VITAMIN E 1.8OZ (Alcohol) Gel [Ningbo Liyuan Daily Chemical Products Co.,Ltd.]
Updated Date: Jun 24, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2019 Category: Drugs & Pharmacology Source Type: alerts

COCONUT GINGER ANTIBACTERIAL HAND (Chloroxylenol) Liquid [Ningbo Liyuan Daily Chemical Products Co., Ltd]
Updated Date: Jun 24, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2019 Category: Drugs & Pharmacology Source Type: alerts

Abbott Gmbh & Co. KG - Alinity c Cuvette Segments - Class 2 Recall
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2019 Category: Medical Devices Source Type: alerts

Abbott Gmbh & Co. KG - Alinity i Processing Module - Class 2 Recall
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2019 Category: Medical Devices Source Type: alerts

Abbott Ireland Diagnostics Division - Alinity i Estradiol Reagent Kit - Class 2 Recall
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2019 Category: Medical Devices Source Type: alerts

Abbott Ireland Diagnostics Division - ARCHITECT Estradiol Reagent Kit - Class 2 Recall
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2019 Category: Medical Devices Source Type: alerts

Abbott Gmbh & Co. KG - Alinity ciseries System Control Module Level Sensor, Bulk Solution Accessory kits, Alinity i and c - Class 2 Recall
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (...
Source: Medical Device Recalls - May 14, 2019 Category: Medical Devices Source Type: alerts

Medica Corporation - Class 2 Recall
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2019 Category: Medical Devices Source Type: alerts

SANITAXE ANTIBACTERIAL AMBER HAND (Chloroxylenol) Liquid [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: May 6, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 6, 2019 Category: Drugs & Pharmacology Source Type: alerts

MEDI-HANDS (Chloroxylenol) Soap [Topmost Chemical Paper Corporation]
Updated Date: May 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 3, 2019 Category: Drugs & Pharmacology Source Type: alerts

Carolina Liquid Chemistries - ETHA RGT. KIT - Class 3 Recall
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2019 Category: Medical Devices Source Type: alerts

CHEMICAL FREE SUNSCREEN (Zinc Oxide) Lotion [Herban Roots, LLC]
Updated Date: May 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 1, 2019 Category: Drugs & Pharmacology Source Type: alerts

Ortho-Clinical Diagnostics - VITROS XT 7600 Integrated System - Class 2 Recall
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2019 Category: Medical Devices Source Type: alerts

Abbott Gmbh & Co. KG - Abbott Alinity i - Class 2 Recall
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2019 Category: Medical Devices Source Type: alerts

Abbott Gmbh & Co. KG - Abbott Alinity c - Class 2 Recall
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure...
Source: Medical Device Recalls - April 19, 2019 Category: Medical Devices Source Type: alerts

NORTH COUNTRY DAIRY SUPPLY PHD (Sulfuric Acid) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

FORMALDEHYDE 37% INHIBITED 7-12% METHANOL (Formaldehyde) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

METZ 0.5% IODINE 5% GLYCERINE TEAT DIP (Iodine) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

METS SOFT KOTE TEAT SPRA (Chlorhexidine) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

SUR-HOOF (Formaldehyde) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

NORTH COUNTRY DAIRY SUPPLY NON IODINE BARRIER DIP (Iodine) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

NORTH COUNTRY DAIRY SUPPLY TD7075 (Iodine) Solution [Surpass Chemical. Company, Inc.]
Updated Date: Apr 18, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2019 Category: Drugs & Pharmacology Source Type: alerts

SANITAXE INSTANT HAND SANITIZER WITH ALOE VERA 27 FL OZ (Ethyl Alcohol) Gel [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 17, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 17, 2019 Category: Drugs & Pharmacology Source Type: alerts

DEODORANT (Benzethonium Chloride) Soap [JIANGSU HANHE DAILY CHEMICALS CO., LTD.]
Updated Date: Apr 16, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 16, 2019 Category: Drugs & Pharmacology Source Type: alerts

Roche Diagnostics Corporation - Roche Diagnostics Tinaquant IgM Gen.2 - Class 2 Recall
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts

DERMAFOAM PREMIUM ANTIBACTERIAL (Benzalkonium Chloride) Soap [Superior Chemical]
Updated Date: Apr 10, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 10, 2019 Category: Drugs & Pharmacology Source Type: alerts

NORTH WOODS SUPREME ANTISEPTIC HAND CLEANSER (Chloroxylenol) Soap [Superior Chemical Corporation]
Updated Date: Apr 10, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 10, 2019 Category: Drugs & Pharmacology Source Type: alerts

NORTH WOODS DERMA FOAM HAND SANITIZER (Benzalkonium Chloride) Soap [Superior Chemical Corporation]
Updated Date: Apr 10, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 10, 2019 Category: Drugs & Pharmacology Source Type: alerts

NORTH WOODS SUPREME ANTISEPTIC HAND CLEANSER (Chloroxylenol) Soap [Superior Chemical Corporation]
Updated Date: Apr 9, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 9, 2019 Category: Drugs & Pharmacology Source Type: alerts

Abbott Laboratories, Inc - Abbott ARCHITECT c16000 Processing Module - Class 2 Recall
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts

Abbott Laboratories, Inc - Abbott ARCHITECT c4000 Processing Module - Class 2 Recall
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts

Abbott Laboratories, Inc - Abbott ARCHITECT c8000 Processing Module - Class 2 Recall
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts

POWER PLAY (Chloroxylenol) Soap [Superior Chemical Corporation]
Updated Date: Apr 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 3, 2019 Category: Drugs & Pharmacology Source Type: alerts

MODESA 2 IN 1 DANDRUFF ALMOND OIL DRY SCALP (Pyrithione Zinc) Shampoo [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 2, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 2, 2019 Category: Drugs & Pharmacology Source Type: alerts

MODESA 2 IN 1 DANDRUFF (Pyrithione Zinc) Shampoo [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 2, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 2, 2019 Category: Drugs & Pharmacology Source Type: alerts

MODESA DANDRUFF EVERYDAY CLEAN (Pyrithione Zinc) Shampoo [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 2, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 2, 2019 Category: Drugs & Pharmacology Source Type: alerts

MODESA 2 IN 1 DANDRUFF GREEN APPLE (Pyrithione Zinc) Shampoo [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 2, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 2, 2019 Category: Drugs & Pharmacology Source Type: alerts

MQDESA 2 IN 1 DANDRUFF (Pyrithione Zinc) Shampoo [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]
Updated Date: Apr 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 1, 2019 Category: Drugs & Pharmacology Source Type: alerts

GLOBAL HOME CARE 19OZ LEMON ANTIBACTERIAL DISH DETERGENT (Chloroxylenol) Liquid [Ningbo Liyuan Daily Chemical Products Co., Ltd.]
Updated Date: Apr 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 1, 2019 Category: Drugs & Pharmacology Source Type: alerts

CHEMICALS (Carduus Marianus, Hepar Suis, Lung Suis, Nux Vomica, Pancreas Suis, Phosphorus, Serum Anguillae, Terebinthina, X-Ray, Zingiber Officinale) Spray [Liddell Laboratories, Inc.]
Updated Date: Mar 26, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 26, 2019 Category: Drugs & Pharmacology Source Type: alerts

Randox Laboratories Ltd. - Fructosamine Control 1 - Class 2 Recall
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2019 Category: Medical Devices Source Type: alerts

Randox Laboratories Ltd. - Fructosamine Control 3 - Class 2 Recall
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2019 Category: Medical Devices Source Type: alerts

Randox Laboratories Ltd. - Fructosamine Calibrator - Class 2 Recall
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista 1500 - Class 2 Recall
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista 500 - Class 2 Recall
Dimension Vista 500, Analyzer, chemistry Model no. 10284473 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2019 Category: Medical Devices Source Type: alerts