Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#201843
FDA device recall Z-1109-2008 · posted 2008-03-19 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CGS
- Quantity affected
- 334 Distributed Worldwide; 164 Domestically
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.
- Date initiated
- 2007-10-12
- Date posted
- 2008-03-19
- Date terminated
- 2012-03-28
- Location
- South Pasadena, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CK (K983070) | Abbott Laboratories | 1999-02-16 |