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
FDA Recall Z-1109-2008 · Posted 2008-03-19
Advertisement
Recalling FirmAbbott Laboratories Inc.
Recall StatusTerminated
Product CodeCGS
Date Initiated2007-10-12
Date Terminated2012-03-28
Product Quantity334 Distributed Worldwide; 164 Domestically
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement