Recall Z-0361-2007 ยท DKJ Colorimetry, Salicylate
Diagnostic Chemicals, Ltd.
Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
| Date | Jan 23, 2007 (initiated Dec 5, 2006) |
| Status | Terminated |
| Reason | Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories |
| Root cause | Other |
| Action | For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits. |
| Quantity | 55 kits shipped to one customer |
| Distribution | PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042329 | SALICYLATE-SL ASSAY Diagnostic Chemicals , Ltd., Dec 27, 2004 |