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U.S. Department of Health and Human Services

Class 3 Device Recall Architect Free T4 MasterCheck

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  Class 3 Device Recall Architect Free T4 MasterCheck see related information
Date Initiated by Firm February 27, 2008
Date Posted July 31, 2008
Recall Status1 Terminated 3 on November 05, 2008
Recall Number Z-1569-2008
Recall Event ID 47236
510(K)Number K984070  
Product Classification Analyte control - Product Code JJX
Product Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05.

Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System.

Abbott Laboratories, Abbott Park, IL 60064
Code Information lots 82130M, Exp 06/30/2008; 82140M, Exp 10/31/2008; and 82150M, Exp 12/31/2008
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, discontinue use of the lots and destroy any remaining inventory. For lots 82140M, 82150M and 84120M, if they know the date the lot was received or the date it was thawed, they may continue to use lots if they have been stored at 2 to 8 degrees C unopened for less than 60 days. If the material has been stored at 2 to 8 degrees C for greater than 60 days or they do not know the number of days it has been thawed, they were instructed to discard the material. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. Customers outside of the U.S., were requested to contact their local customer support representative.
Quantity in Commerce 197 units
Distribution Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.
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 = JJX and Original Applicant = BIO-RAD
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