Recall Z-1109-2008 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Abbott Laboratories Inc.
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030
| Date | Mar 19, 2008 (initiated Oct 12, 2007) |
| Status | Terminated |
| Reason | Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems. |
| Root cause | Nonconforming Material/Component |
| Action | On October 12, 2007, A Product Recall letter was provided to all Clinical Chemistry Creatine Kinase Reagent customers that have received lot number 52044HW00 . Customer reply form were included in all US customers letter. The letter instructed customers to discontinue use of the kits and destroy them following their laboratory procedure, and document the number of kits discarded. Abbott will provide reimbursement for destroyed kits. |
| Quantity | 334 Distributed Worldwide; 164 Domestically |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983070 | CK Abbott Laboratories, Feb 16, 1999 |