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HIV-1/2 Antibody Test Controls
MedMira Laboratories Inc · Model 815311007590 · UDI-DI 00628451188209
0
510(k) clearances
3,206
Adverse events (4 deaths)
1
Recalls
37
Facilities
Description
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
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.