BEUDAMED
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    DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·July 21, 2021

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

    FDA Recall
    Terminated ·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munich Germany·Product code JJE·June 17, 2020

    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."

    FDA Recall
    Terminated ·Ameditech Inc·Product code DIO·August 18, 2020

    iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·September 10, 2010

    IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

    FDA Recall
    Terminated ·International Technidyne Corp.·Product code JPA·May 10, 2011

    Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

    FDA Recall
    Terminated ·International Technidyne Corp.·Product code JPA·May 10, 2011

    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300)"

    FDA Recall
    Terminated ·Ameditech Inc·Product code LDJ·August 18, 2020

    Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code KCT·July 30, 2014

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code GDZ·March 11, 2016

    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code LRW·October 28, 2016

    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code GEN·October 28, 2016

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Recall
    Terminated ·Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario·Product code KIS·April 12, 2013

    Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KXA·September 26, 2007