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U.S. Department of Health and Human Services

Class 3 Device Recall ST AIA PACK TT3

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  Class 3 Device Recall ST AIA PACK TT3 see related information
Date Initiated by Firm January 26, 2006
Date Posted February 23, 2006
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-0558-06
Recall Event ID 34547
510(K)Number K936229  
Product Classification Radioimmunoassay, Total Triiodothyronine - Product Code CDP
Product TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum.
Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels.
Code Information Lot #FX17440. The inner foil packs contain an ''incorrect'' expiration date of 10/2005. The outer box is labeled with the ''correct'' expiration date of 10/2006.
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Road
Grove City OH 43123
For Additional Information Contact Charles Gill
614-317-1909
Manufacturer Reason
for Recall		 The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a letter, dated 1/26/06, to all consignees.
Quantity in Commerce 9 boxes
Distribution KS, GA, TX, WI
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 = CDP and Original Applicant = TOSOH MEDICS, INC.
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