Reported Dec 7, 2022 · Ongoing
CMV IgM EIA, in vitro diagnostic.
Bio-Rad Laboratories, 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: Bio-Rad Laboratories, Inc. · 6565 185th Ave Ne · Redmond, WA · 98052-5039
Is this the product you have?
- CMV IgM EIA, in vitro diagnostic.
- Lot codes and dates
- Catalog Number25178
- UDI-DI Code00847865010733
- Lot NumbersB02022 E10022 G05022
- Amount recalled
- 180 kits
Where it was sold
Why it was recalled
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
This product could cause temporary or reversible health problems — stop using it.
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