Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
FDA device recall Z-0361-2007 · posted 2007-01-23 · Terminated
Recall details
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DKJ
- Quantity affected
- 55 kits shipped to one customer
- Distribution
- PA
- Date initiated
- 2006-12-05
- Date posted
- 2007-01-23
- Date terminated
- 2016-01-27
- Location
- Charlottetown Canada, Prince Edward Island
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALICYLATE-SL ASSAY (K042329) | Diagnostic Chemicals , Ltd. | 2004-12-27 |