Roche Elecsys total PSA CalSet, catalog number 11731696322.
FDA device recall Z-0382-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
- Action taken
- Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- LTJ
- Quantity affected
- 25,000 kits
- Distribution
- Nationwide.
- Date initiated
- 2005-12-07
- Date posted
- 2006-01-11
- Date terminated
- 2006-02-26
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.