FDA Recall
Terminated
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.
Recall: Z-1021-04
·
Initiated May 5, 2004
Recall
- Recall Number
- Z-1021-04
- Event Number
- 29061
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 5, 2004
- Posted
- July 20, 2004
- Terminated
- July 24, 2007
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
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.
Reason
The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
Action
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
Distribution
California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.
Quantity
8