Home › Alere Scarborough, Inc. › Alere Determine™ HIV–1/2 Ag/Ab Combo Controls
Alere Determine™ HIV–1/2 Ag/Ab Combo Controls
Alere Scarborough, Inc. · Model 7D2628 · UDI-DI 10811877010347
MZF
Prescription
0
510(k) clearances
3,206
Adverse events (4 deaths)
1
Recalls
37
Facilities
Description
The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
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.
