Recall Z-1109-2008
Abbott Laboratories Inc. · initiated October 12, 2007
Product
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
Codes / lots: Lot Number: 52044HW00
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1109-2008
- Initiated
- October 12, 2007
- Posted by FDA
- March 19, 2008
- Terminated
- March 28, 2012
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Quantity
- 334 Distributed Worldwide; 164 Domestically
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.
- Recalling firm
- Abbott Laboratories Inc., South Pasadena, CA