Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793 Recalled by Ortho Clinical Diagnostics Inc Due to The recalling firm determined that biased results may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho Clinical Diagnostics Inc directly.
Affected Products
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Quantity: 1790
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho Clinical Diagnostics Inc
Ortho Clinical Diagnostics Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report