BEUDAMED
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    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

    BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code KPA·August 31, 2020

    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JHS·August 15, 2024

    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code LPS·October 17, 2024

    cobas infinity central lab, Material Number 07154003001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JQP·December 12, 2022

    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·January 20, 2026

    The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JZO·November 21, 2025

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020

    Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020

    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code KPA·August 31, 2020

    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·April 26, 2021

    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code GHH·October 3, 2023

    cobas e801 Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022

    Ventana HE 600 System, automated slide preparer, for use in laboratories.

    FDA Recall
    Open, Classified ·Ventana Medical Systems Inc·Product code KPA·June 1, 2022

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Recall
    Open, Classified ·Ventana Medical Systems, Inc.·Product code NJT·June 27, 2024