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SPOTCHECK

ASTORIA-PACIFIC, INC. · Model 80-0900P4K · UDI-DI 00725609000441

JJT Prescription
1
510(k) clearances
18
Adverse events
2
Recalls
15
Facilities

Description

Positive Controls, Pkg/4

Recalls

DateFirmReason
2012-07-19Abbott Point Of Care Inc.Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12
2003-01-08PerkinElmer LIfe Sciences IncThe Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

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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.