medical Class II Updated 2019-02-13

Abbott Ireland Diagnostics Division recalls ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or

Recalled Product

ARCHITECT Total 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: List number (Kit Configuration): 7K64 20 (4 x 100 test/kit), 7K64 25 (1 x 100 tests/kit), 7K64 30 (4 x 500 tests/kit), 7K64 35 (1 x 500 tests/kit), 7K64 27 (1 x 100 tests/kit), 7K64 32 (4 x 500 tests/kit), 7K64 37 (1 x 500 tests/kit). All lot codes for each of these list numbers are included in the recall.

View official government recall

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