EXEGEN ATM MINISWINE (Patm-Neo) Not Applicable [Exemplar Genetics, Llc]
Updated Date: Apr 8, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 8, 2019 Category: Drugs & Pharmacology Source Type: alerts

Luminex Corporation - Verigene Enteric Pathogens Nucleic Acid Test (EP) - Class 2 Recall
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts

Genetic Edge Compounds Issues Voluntary Nationwide Recall of GEC Laxoplex Dietary Supplement Capsules Due to Presence of Anabolic Steroids
Genetic Edge Compounds is voluntarily recalling all lot codes distributed between February 2, 2015- May 2, 2017 of GEC Laxoplex dietary supplement capsules, packaged in a white plastic bottle containing 60 capsules to the retail level and consumer level. Food and Drug Administration ( “FDA”) analysis has found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - May 6, 2017 Category: Medical Law Source Type: alerts

PerkinElmer Life and Analytical Sciences, Wallac, OY - Genetic Screening Processor (GSP - Class 2 Recall
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2017 Category: Medical Equipment Source Type: alerts

Genetic Testing Institute,inc - PF4 Concentrated Wash - Class 2 Recall
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2015 Category: Medical Equipment Source Type: alerts

ACCEL CHG (Chlorhexidine Gluconate) Liquid [Accelerated Genetics]
Updated Date: Dec 26, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - December 26, 2014 Category: Drugs & Pharmacology Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: -...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

BioFire Diagnostics, Inc. - FilmArray Blood Culture Identification (BCID) Panel - Class 2 Recall
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Str...
Source: Medical Device Recalls - June 21, 2014 Category: Medical Equipment Source Type: alerts

ACCEL GOLD KOTE (Bronopol) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

ACCEL DIP 1000 (Iodine) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

ACCEL DIP 500 (Iodine) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

ACCEL OXY (Hydrogen Peroxide) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

ACCEL CHG DIP (Chlorhexidine Gluconate) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

ACCEL KOTE (Iodine) Liquid [Accelerated Genetics]
Updated Date: Jan 2, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 2, 2014 Category: Drugs & Pharmacology Source Type: alerts

Atossa Genetics, Inc. - ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) - Class 1 Recall
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. ...
Source: Medical Device Recalls - October 29, 2013 Category: Medical Equipment Source Type: alerts

Genetic Testing Institute,inc - LIFECODES PF4 Enhanced assay - Class 2 Recall
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 29, 2013 Category: Medical Equipment Source Type: alerts