Reported Aug 21, 2024 · Ongoing
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
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. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Lot codes and dates
Model No 1513266UDI/GTIN# 110758750009237
- Lots within expiry
33803390340034103422343034403450346134713480
- Amount recalled
- 18,467 units
Where it was sold
- Nationwide
Why it was recalled
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
This product could cause temporary or reversible health problems — stop using it.
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