BEUDAMED
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    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·August 10, 2016

    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 Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·March 11, 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 Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 14, 2026

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

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·November 27, 2024

    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 Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·October 2, 2024

    cobas infinity central lab, Material Number 07154003001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 18, 2023

    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the host.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 25, 2019

    RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 4, 2013

    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 7, 2016

    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 19, 2020

    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015