Reported Oct 10, 2018 · Ongoing
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 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 (10758750000302) 1931922
- Lot codes and dates
- 2470 2480 2490 2500 2510 2520 2530
- Amount recalled
- 1955
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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