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REMEL, INC. · Model R2451030 · UDI-DI 00848838026904

MHJ
10
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities

Recalls

DateFirmReason
2002-05-09Remel, Inc.A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may

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Data 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.