FDA Medical Device Recalls (openFDA)
Diagnostic Chemicals, Ltd.: Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
- Recall number
- Z-0361-2007
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Product
- Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
- Status
- Terminated
- Initiated
- 2006-12-05
- Posted
- 2007-01-23
- Terminated
- 2016-01-27
- 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
- Lot, serial or model codes
- Lot 29892
- 510(k) numbers
- ["K042329"]
- PMA numbers
- not on file
- Product code
- DKJ
- Firm FEI
- 3002806809
- Firm city
- Charlottetown Canada
- Firm state
- Prince Edward Island
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28