Reported May 25, 2022 · Ongoing
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc · 1001 Us Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
- Lot codes and dates
- Until further notice, future lots will also be affected
- UDI10758750000302
- Affected Lot Number/ Expiration Date
3100 01-MAR-20223111 25-MAR-20223120 04-APR-20223130 25-APR-20223140 10-MAY-20223145 10-MAY-20223150 30-MAY-20223160 09-JUN-20223170 22-JUN-20223180 02-AUG-20223190 16-AUG-20223200 06-SEP-20223210 12-SEP-2022
- Amount recalled
- 2502 total: 2154 US; 348 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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