—#46884

Product

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

FDA product code: GTQ — Antistreptolysin - Titer/Streptolysin O Reagent
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot 674653; exp. 12/31/2006.

Why it was recalled

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)

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.

Timeline

Recall initiated: 2006-07-25
Posted by FDA: 2006-08-09
Terminated: 2007-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.