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Alere Determine™ HIV–1/2 Ag/Ab Combo
Alere Scarborough, Inc. · Model 7D2648 · UDI-DI 10811877010293
0
510(k) clearances
3,206
Adverse events (4 deaths)
1
Recalls
37
Facilities
Description
Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
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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