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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

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 Class 2 Device Recall SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORsee related information
Date Initiated by FirmOctober 22, 2007
Date PostedSeptember 30, 2009
Recall Status1 Terminated 3 on July 16, 2012
Recall NumberZ-2238-2009
Recall Event ID 48191
510(K)NumberK014173 
Product Classification Colorimetry, salicylate - Product Code DKJ
ProductSYNCHRON 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.
Code Information Lot Numbers: M705222 and M706238.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact
760-438-9151
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn "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 Commerce7,842 total
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DKJ
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