Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl sibutramine
, Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - October 6, 2017 Category: Medical Law Source Type: alerts
The Binding Site Group, Ltd. - Human Alpha1Antitrypsin Kit - Class 2 Recall
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2017 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Sekure Chemistry Acetaminophen L3K - Class 2 Recall
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts
Leica Biosystems Richmond Inc. - Napsin A (MRQ60 Mab) CM - Class 2 Recall
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts
Leica Biosystems Richmond Inc. - SOX10 (Polyclonal) CM - Class 2 Recall
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts
Leica Biosystems Richmond Inc. - Glypican3 (1G12 Mab) CM - Class 2 Recall
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts
Leica Biosystems Richmond Inc. - PAX8 (MRQ50 Mab) CM - Class 2 Recall
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts
Soft Computer Consultants, Inc. - SoftLab - Class 2 Recall
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 2, 2017 Category: Medical Devices Source Type: alerts
PerkinElmer Health Sciences, Inc. - PerkinElmer 226 Sample Collection Device - Class 3 Recall
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2017 Category: Medical Devices Source Type: alerts
O-Two Medical Technologies, Inc. - Timer, General Laboratory - Class 2 Recall
O-Two Adult Ventilation Timer MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS CATALOG #(s): 01BM1000 INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2017 Category: Medical Devices Source Type: alerts
RED BETTER SPOT CORRECTOR NON-DRYING ACNE BALM (Salicylic Acid, Sulfur) Cream [SKIN SCIENCES LABORATORY INC.]
Updated Date: May 30, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 30, 2017 Category: Drugs & Pharmacology Source Type: alerts
Merge Healthcare, Inc. - Merge LIS - Class 2 Recall
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2017 Category: Medical Devices Source Type: alerts
Implant Direct Sybron Manufacturing, LLC - Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD - Class 2 Recall
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2017 Category: Medical Devices Source Type: alerts
VMV HYPOALLERGENICS ID SKIN-BUFFING CLEANSING SCRUB (Salicylic Acid) Emulsion [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
ID CLARIFYING BODY (Salicylic Acid) Soap [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
