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.
FDA Recall Z-2238-2009 · Posted 2009-09-30
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Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeDKJ
Date Initiated2007-10-22
Date Terminated2012-07-16
Product Quantity7,842 total
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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