Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
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-0999-04
- Quantity
- 11
- 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 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615).
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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