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

Recall date

July 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1075-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, C…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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