Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
FDA device recall Z-0999-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Tecan software has the potential to match the patient with a different patient's test results.
- Action taken
- Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQW
- Quantity affected
- 11
- Distribution
- Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, 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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