COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150
FDA device recall Z-1021-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
- Action taken
- Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 8
- Distribution
- California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.
- Date initiated
- 2004-05-05
- Date posted
- 2004-07-20
- Date terminated
- 2007-07-24
- Location
- Indianapolis, IN
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