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REMEL, INC. · Model R30851502 · UDI-DI 00848838080913
10
510(k) clearances
2
Adverse events
3
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-03 | Immuno-Mycologics, Inc | The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a sma |
| 2018-03-30 | Immuno-Mycologics, Inc | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results |
| 2016-12-27 | Immuno-Mycologics, Inc | The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who repo |
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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.