—#43401

Product

Roche Elecsys total PSA CalSet, catalog number 11731696322.

FDA product code: LTJ — Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device class: Class 2
Medical specialty: Immunology
PMA numbers: P990056S001
Affected lot / code info: Lot 171735.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-12-07
Posted by FDA: 2006-01-11
Terminated: 2006-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43401. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.