Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
FDA Recall Z-1385-06 · Posted 2006-08-09
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeGTQ
Date Initiated2006-07-25
Date Terminated2007-04-18
Product Quantity20 kits.
Reason for Recall
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)
Firm Action
Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
Root Cause
Other
Distribution Pattern
Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.