Recall Z-1076-2019 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Abbott Laboratories, Inc
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
| Date | Jul 18, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | Recall letters were issued via FedEx overnight priority mail on 7/18/2018. |
| Quantity | 30 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983070 | CK Abbott Laboratories, Feb 16, 1999 |