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Alinity

Abbott GmbH · Model 08P0712 · UDI-DI 00380740136574

MZF Prescription
0
510(k) clearances
3,187
Adverse events (4 deaths)
1
Recalls
37
Facilities

Description

Alinity i HIV Ag/Ab Combo Controls

Recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.