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IMMY
Immuno-Mycologics, Inc. · Model CRY101 · UDI-DI 00816387020759
MDU
Prescription
2
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities
Description
Cryptococcus Antigen EIA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-17 | Meridian Bioscience Inc | 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 patien |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
