FDA Device

Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653

Hazard

The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)

What You Should Do

Remedy

Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.

Products

Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
Brand
Roche Diagnostics Corp.
UPC
Lot 674653; exp. 12/31/2006.

Units Affected

20 kits.