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FDAJuly 18, 2018device

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

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

The hazard

The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

UPCs

00380740012878

Recall history

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

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Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. — Recall Details · AllClear