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HIV-1 Antibody Test Controls
MedMira Laboratories Inc · Model 815311007590 · UDI-DI 00628451188087
0
510(k) clearances
3,206
Adverse events (4 deaths)
1
Recalls
37
Facilities
Description
HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
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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.