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OraQuick HIV Self-Test
Orasure Technologies, Inc. · Model 3001-3822U · UDI-DI 00608337001808
0
510(k) clearances
3,206
Adverse events (4 deaths)
1
Recalls
37
Facilities
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.