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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron LX and UniCel DxC Synchron Clinical Systems

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  Class 2 Device Recall Synchron LX and UniCel DxC Synchron Clinical Systems see related information
Date Initiated by Firm April 15, 2010
Date Posted September 09, 2010
Recall Status1 Terminated 3 on December 31, 2013
Recall Number Z-2388-2010
Recall Event ID 55359
510(K)Number K042291  K060256  K965240  K023049  K011213  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),
Code Information All non-expired lots are affected by the recall.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
FDA Determined
Cause 2		 Other
Action Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .
Quantity in Commerce 84,186 units (79,071 in US & 5,115 in Canada)
Distribution Worldwide Distribution: USA and Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CGA and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = CGA and Original Applicant = BECKMAN INSTRUMENTS, INC.
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