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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 5, 2004
- Posted
- July 20, 2004
- Terminated
- July 24, 2007
- Recall Number
- Z-1021-04
- Quantity
- 8
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
Distribution
California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.
Lot / Code Info
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .
Root Cause
Other
Action Taken
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
More recalls by Roche Diagnostics Corp.
Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN.
Test str...
Sep 16, 2009
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test str...
Sep 16, 2009
Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190.
Cal...
Sep 10, 2009