Roche Diagnostics Corp. Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot 674653, exp. 12/31/2006.
Products Sold
Lot 674653; exp. 12/31/2006.
Roche Diagnostics Corp. is recalling Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 119 due to 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. (extreme. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026