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FDAOctober 12, 2018device

ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.

What to do

FDA enforcement status: Terminated

Brands named

abbott ireland diagnostics divisionabbottabbott ireland

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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