Z-0361-2007

Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

Name: Z-0361-2007 Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
Creator: Diagnostic Chemicals, Ltd.
Published: 2006-12-05
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2006-12-05 / Terminated

FDA source

Diagnostic Chemicals, Ltd. began a recall of Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892 on 2006-12-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0361-2007
Status: Terminated
Initiated: 2006-12-05
Posted: 2007-01-23
Terminated: 2016-01-27
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Product: Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
Product code: DKJ Colorimetry, Salicylate
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
FDA 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 in commerce: 55 kits shipped to one customer
Distribution: PA
Product codes and lots: Lot 29892

Product code DKJ

K042329Class IISalicylate-Sl AssayDiagnostic Chemicals , Ltd. / cleared 2004-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)