Z-0382-06

Roche Elecsys total PSA CalSet, catalog number 11731696322

Name: Z-0382-06 Roche Elecsys total PSA CalSet, catalog number 11731696322
Creator: Roche Diagnostics Corp.
Published: 2005-12-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-12-07 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche Elecsys total PSA CalSet, catalog number 11731696322 on 2005-12-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0382-06
Status: Terminated
Initiated: 2005-12-07
Posted: 2006-01-11
Terminated: 2006-02-26
Recalling firm: Roche Diagnostics GmbH
Product: Roche Elecsys total PSA CalSet, catalog number 11731696322.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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.
FDA root cause: Other
Action: Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
Quantity in commerce: 25,000 kits
Distribution: Nationwide.
Product codes and lots: Lot 171735.

Product code LTJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)