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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Ortho Clinical Diagnostics Inc: The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

Agency Publication Date: October 3, 2018
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Affected Products

Product: VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

2470 2480 2490 2501 2510 2521

Product: VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

2470 2480 2490 2500 2510 2520 2530

Product: VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

2330 2340 2350 2360 2370 2380

Product: VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80717
Status: Active
Manufacturer: Ortho Clinical Diagnostics Inc
Manufactured In: United States
Units Affected: 4 products (7880; 1955; 1790; 68230)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.