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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CGS
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