Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling 30 kits of Abbott ARCHITECT Creatinine Kinase (Lot number 99633UN18, expiration 02JAN19) due to a stability issue. The problem may cause an error code reading "Unable to calculate result, reaction check failure" and/or Quality Control results that are out of range low. The affected product was distributed nationwide in the United States and Puerto Rico, as well as to government and military facilities, and to numerous countries internationally including Canada, Australia, China, Brazil, and many others.
The recall notice does not specify a remedy or instructions for what affected consumers should do with the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 30 kits Lot/code info: Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.