Recall Z-1385-06 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Roche Diagnostics Corp.
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
| Date | Aug 9, 2006 (initiated Jul 25, 2006) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product. |
| Quantity | 20 kits. |
| Distribution | Nationwide including the states of Arizona, California, New Jersey and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.