FDA Device Intelligence
HomeAbbott GmbH › Alinity

Alinity

Abbott GmbH · Model 08P0702 · UDI-DI 00380740146252

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

Description

Alinity i HIV Ag/Ab Combo Calibrator

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

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 docs
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.