Beckman Coulter Inc. - iChem(R) VELOCITY Urine Chemistry Strips - Class 2 Recall
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH,...
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts
Inpeco S.A. - FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) - Class 2 Recall
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - BECKMAN COULTER iChemVELOCITY - Class 2 Recall
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible ...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BD MAX DNA MMK (SPC) - Class 3 Recall
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2018 Category: Medical Devices Source Type: alerts
PerkinElmer Life and Analytical Sciences, Wallac, OY - PerkinElmer Specimen Gate Screening Center - Class 2 Recall
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2018 Category: Medical Devices Source Type: alerts
The Binding Site Group, Ltd. - Beta2Microglobulin Urine Kit - Class 2 Recall
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2018 Category: Medical Devices Source Type: alerts
Quidel Corporation - Sofia 2 - Class 2 Recall
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2018 Category: Medical Devices Source Type: alerts
Stanbio Laboratory, LP - RF Latex Reagent - Class 2 Recall
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2018 Category: Medical Devices Source Type: alerts
ZOLL Medical Corporation - OneStep CPR Complete - Class 2 Recall
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2018 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - HemosIL ReadiPlasTin - Class 2 Recall
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 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 - March 4, 2018 Category: Medical Devices Source Type: alerts
FEEL BETTER NOW (Lidocaine) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: Mar 1, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 1, 2018 Category: Drugs & Pharmacology Source Type: alerts
The Binding Site Group, Ltd. - Rheumatoid Factor (RF) Kit for use on SPAPLUS - Class 2 Recall
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2018 Category: Medical Devices Source Type: alerts
GREAT II LOTIONIZED ANTISEPTIC (Chloroxylenol) Soap [MEYER LABORATORY]
Updated Date: Feb 8, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 8, 2018 Category: Drugs & Pharmacology Source Type: alerts
NUMB SOOTHE (Lidocaine) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: Jan 19, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 19, 2018 Category: Drugs & Pharmacology Source Type: alerts
Ortho-Clinical Diagnostics - enGen Laboratory Automation System - Class 2 Recall
enGen Track System with TCAutomation Software Version 4.2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2017 Category: Medical Devices Source Type: alerts
