ID ANTI ACNE (Salicylic Acid) Lotion [SKIN SCIENCES LABORATORY INC.]
Updated Date: May 15, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 15, 2017 Category: Drugs & Pharmacology Source Type: alerts
Ortho-Clinical Diagnostics - enGen (TM) Laboratory Automation Systems - Class 2 Recall
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts
ID ANTI-ACNE TONER CLARIFYING FACE PLUS BODY TREATMENT (Salicylic Acid) Liquid [SKIN SCIENCES LABORATORY INC.]
Updated Date: May 10, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 10, 2017 Category: Drugs & Pharmacology Source Type: alerts
Siemens Healthcare Diagnostics Inc - RAPIDPoint 500 Blood Gas Analyzer - Class 2 Recall
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2017 Category: Medical Equipment Source Type: alerts
Avid Medical, Inc. - Vacutainer Tubes - Class 2 Recall
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2017 Category: Medical Equipment Source Type: alerts
GAMMAPLEX (Human Immunoglobulin G) Solution [Bio Products Laboratory Limited]
Updated Date: Apr 10, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 10, 2017 Category: Drugs & Pharmacology Source Type: alerts
Becton Dickinson & Company - BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes - Class 2 Recall
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts
ESSENCE SKIN-SAVING ANTIPERSPIRANT (Aluminum Chlorohydrate) Spray [SKIN SCIENCES LABORATORY INC.]
Updated Date: Apr 4, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 4, 2017 Category: Drugs & Pharmacology Source Type: alerts
PerkinElmer Life and Analytical Sciences, Wallac, OY - Specimen Gate Laboratory - Class 2 Recall
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2017 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - EpiCenter Plus Microbiology Data Management System - Class 2 Recall
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act ...
Source: Medical Device Recalls - February 28, 2017 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Company - BD Vacutainer(R) Brand Plus PST Separation Tubes - Class 2 Recall
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2017 Category: Medical Equipment Source Type: alerts
ORAZN (Zinc Gluconate) Gel [Addison Biological Laboratory, Inc.]
Updated Date: Feb 10, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 10, 2017 Category: Drugs & Pharmacology Source Type: alerts
Roche Diagnostics Operations, Inc. - TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive) - Class 2 Recall
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods o...
Source: Medical Device Recalls - January 25, 2017 Category: Medical Equipment Source Type: alerts
Roche Diagnostics Operations, Inc. - Cobas b 123 POC system - Class 2 Recall
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2017 Category: Medical Equipment Source Type: alerts
PerkinElmer Health Sciences, Inc. - Specimen Gate Laboratory eReports - Class 2 Recall
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2016 Category: Medical Equipment Source Type: alerts
