Recall Z-1075-2019
Abbott Laboratories, Inc · initiated July 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Codes / lots: 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.
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.
FDA-determined cause: Material/Component Contamination
Action taken
Recall letters were issued via FedEx overnight priority mail on 7/18/2018.
Details
- Recall number
- Z-1075-2019
- Initiated
- July 18, 2018
- Terminated
- August 13, 2020
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Quantity
- 6,187 kits kits
- 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…
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1076-2019 Class II | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.The product has a stability issue which may lead to an error code indicating "Unable to calculate result… | 07/18/2018Terminated |