Recall Z-0382-06 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Roche Diagnostics Corp.
Roche Elecsys total PSA CalSet, catalog number 11731696322.
| Date | Jan 11, 2006 (initiated Dec 7, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05. |
| Quantity | 25,000 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.