Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
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-1001-04
- Quantity
- 8
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Tecan software has the potential to match the patient with a different patient's test results.
Distribution
Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, 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 user laboratories.
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