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U.S. Department of Health and Human Services

Class 2 Device Recall Clinical Chemistry Creatine Kinase

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  Class 2 Device Recall Clinical Chemistry Creatine Kinase see related information
Date Initiated by Firm October 12, 2007
Date Posted March 19, 2008
Recall Status1 Terminated 3 on March 28, 2012
Recall Number Z-1109-2008
Recall Event ID 46387
510(K)Number K983070  
Product Classification cpk or isoenzymes nad reduction - Product Code CGS
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
Code Information Lot Number: 52044HW00
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Mark Littlefield
972-518-6062
Manufacturer 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 2		 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 in Commerce 334 Distributed Worldwide; 164 Domestically
Distribution Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGS and Original Applicant = ABBOTT LABORATORIES
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