Z-2238-2009

SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with...

Name: Z-2238-2009 SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with...
Creator: Beckman Coulter Inc
Published: 2007-10-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-10-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800... on 2007-10-22. The reason FDA records is "The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2238-2009
Status: Terminated
Initiated: 2007-10-22
Posted: 2009-09-30
Terminated: 2012-07-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.
Product code: DKJ Colorimetry, Salicylate
Reason for recall: The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An "Urgent: Product Corrective Action" letter dated October 22, 2007 was issued to customers. Customers were instructed to do the following: 1) Discontinue use and discard appropriately the affected lots of Salicylate Reagent., 2) Contact your Customer Service Representatives at 1-800-526-3821 in the United States or local Beckman Coulter Representative to discuss replacement options and 3) Complete and return the enclosed response form within 10 days. Contact your Customer Service Representative at 1-800-526-3821 in the United States or 1-800-463-7828 in Canada or, if you are outside the United States or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. Direct any questions regarding this Product Corrective Action letter to the Customer Support Center (Hotline) at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, please contact your local Beckman Coulter Representative.
Quantity in commerce: 7,842 total
Distribution: Nationwide and Canada.
Product codes and lots: Lot Numbers: M705222 and M706238.

Product code DKJ

K014173Class IISynchron Systems Salicylate Reagent and CalibratorBeckman Coulter, Inc. / cleared 2002-02-15

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)