Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311,…
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Read the official notice →- Date
- 2023-11-29
- Country
- United States
- Brand
- Roche Diagnostics Operations
- Product
- Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502;…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
FDA · DeviceRoche Diagnostics Operations, Inc.US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,Official notice → - 2024-10-02
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Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
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A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information…
FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice → - 2022-08-17
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Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo…
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Roche Diagnostics Operations, Inc. recalls Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the…
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Other drugs & medical recalls in the United States
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Sage Products Inc recalls stryker Sage PrimaFit External Urine Management System for the Female Anatomy
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Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
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