medical Class II Updated 2019-04-10

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 87697UN18, exp. 22OCT18; UDI (01)00380740012878 (17)181022(10)87697UN18; Lot number 99632UN18, exp. 12NOV18, UDI (01)00380740012878 (17)181112(10)99632UN18; and Lot 24358UN18, exp. 05DEC18, UDI (01)00380740012878 (17)181205(10)24358UN18.
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