Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 Recalled by Ortho-Clinical Diagnostics, Inc Due to Falsely high or delayed patient and QC results...
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 FSH Reagent Pack- IVD 1931922
Quantity: 2502 total: 2154 US; 348 OUS
Why Was This Recalled?
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc
Ortho-Clinical Diagnostics, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report