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

Is my product affected?

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

• UPC 00380740012878

Check against the official notice below — it lists the full affected range.

What happened

Abbott Laboratories is recalling 6,187 kits of Abbott ARCHITECT Creatine Kinase due to a stability issue. The affected product may generate an error code stating "Unable to calculate result, reaction check failure" and/or produce Quality Control results that are out of range low. The recalled kits include three lot numbers: 87697UN18 (expiration 22OCT18), 99632UN18 (expiration 12NOV18), and 24358UN18 (expiration 05DEC18). The product was distributed nationwide in the United States and Puerto Rico, as well as to government and military facilities and to numerous countries internationally.

The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, Quantity: 6,187 kits kits 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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