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U.S. Department of Health and Human Services

Class 2 Device Recall TinaQuant ASLO

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  Class 2 Device Recall TinaQuant ASLO see related information
Date Initiated by Firm July 25, 2006
Date Posted August 09, 2006
Recall Status1 Terminated 3 on April 18, 2007
Recall Number Z-1385-06
Recall Event ID 35791
Product Classification Anti-streptolysin O Reagent - Product Code GTQ
Product Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
Code Information Lot 674653; exp. 12/31/2006.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
Quantity in Commerce 20 kits.
Distribution Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.
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.
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