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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm May 05, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 24, 2007
Recall Number Z-1021-04
Recall Event ID 29061
Product COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
Code Information All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-1247
Manufacturer Reason
for Recall		 The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
FDA Determined
Cause 2		 Other
Action Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
Quantity in Commerce 8
Distribution California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.
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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