Reported Jan 23, 2019 · Terminated
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay…
Meridian Bioscience 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: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023
Is this the product you have?
- PREMIER Cryptococcal Antigen
- Catalog Number 602096 Product UsageThe PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF)
- Lot codes and dates
- Lot Numbers
602096K089602096K090602096K091
- Lot Numbers
- Amount recalled
- 184
Where it was sold
Why it was recalled
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
This product could cause temporary or reversible health problems — stop using it.
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