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Alinity

Abbott GmbH · Model 08P0420 · UDI-DI 00380740135201

JIQ Prescription
10
510(k) clearances
20
Adverse events
1
Recalls
21
Facilities

Description

Alinity c Microalbumin Reagent Kit 640 Tests

Recalls

DateFirmReason
2012-11-07HemoCue ABIncorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the

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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.