FDA Device

Roche Elecsys total PSA, catalog number 11731262322.

Hazard

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.

What You Should Do

Remedy

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

Products

Roche Elecsys total PSA, catalog number 11731262322.
Brand
Roche Diagnostics Corp.
UPC
Lot 171640.

Units Affected

25,000 kits