Home › Biolytical Laboratories Inc › INSTI HIV-1/HIV-2 Test Controls
INSTI HIV-1/HIV-2 Test Controls
Biolytical Laboratories Inc · Model 80-1037 · UDI-DI 06865978010376
0
510(k) clearances
3,187
Adverse events (4 deaths)
1
Recalls
37
Facilities
Description
INSTI HIV-1/HIV-2 Test Controls
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.