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IMMCO DIAGNOSTICS
IMMCO DIAGNOSTICS, INC. · Model 1107X · UDI-DI 00845714001048
DBL
Prescription
10
510(k) clearances
1
Adverse events
1
Recalls
8
Facilities
Description
COMVI Mouse Kidney/Stomach IFA Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-07-29 | Bio-Rad Laboratories | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit. |
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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.