MINIDROPS (Lubricant Eye Drops) Liquid [Optics Laboratory, Inc]
Updated Date: Feb 25, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 25, 2019 Category: Drugs & Pharmacology Source Type: alerts
Roche Diagnostics Corporation - Elecsys Anti HAV IgM - Class 2 Recall
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms o...
Source: Medical Device Recalls - January 30, 2019 Category: Medical Devices Source Type: alerts
ORTHO-CLINICAL DIAGNOSTICS - VITROS HBeAg Reagent - Class 2 Recall
VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. T...
Source: Medical Device Recalls - January 4, 2019 Category: Medical Devices Source Type: alerts
OCCUFRESH (Water) Liquid [Optics Laboratory, Inc]
Updated Date: Dec 18, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 18, 2018 Category: Drugs & Pharmacology Source Type: alerts
Tosoh Bioscience Inc - Hemoglobin A1c Control - Class 3 Recall
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Biosciences - DeltaVision OMX SR Imaging System - Class 2 Recall
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 21, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - SortingDrive Professional Part, SortingDrive Professional Kit, (Sorting Drive Software v4.2.1) - Class 3 Recall
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2.1 Software DVD (PN B95346). This software version includes an option for manual barcode printing for sample tubes. Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - SortingDrive Product Part, SortingDrive Plus Kit (Sorting Drive Software v4.2.1) - Class 3 Recall
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Acumedia Manufacturers, Inc. - Palcam Agar Base, Acumedia - Class 3 Recall
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2018 Category: Medical Devices Source Type: alerts
Acumedia Manufacturers, Inc. - Campylobacter Blood Free Selective Medium - Class 3 Recall
Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2018 Category: Medical Devices Source Type: alerts
Data Innovations, LLC - IM Abbott Alinity ciseries (abdicqii) accessory driver - Class 2 Recall
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2018 Category: Medical Devices Source Type: alerts
Hologic, Inc - Tomcat Instrument - Class 2 Recall
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - HemosIL ReadiPlasTin - Class 2 Recall
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2018 Category: Medical Devices Source Type: alerts
Leica Microsystems, Inc. - HistoCare SPECTRA ST Stainer - Class 2 Recall
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
Radiometer America Inc - The ABL90 FLEX Analyzer - Class 2 Recall
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2018 Category: Medical Devices Source Type: alerts
