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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC and Synchron LX Clinical Systems

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  Class 2 Device Recall UniCel DxC and Synchron LX Clinical Systems see related information
Date Initiated by Firm September 02, 2010
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 30, 2014
Recall Number Z-0452-2012
Recall Event ID 59562
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product UniCel DxC and Synchron LX Clinical Systems 100 ¿L Sample Syringe, 100UL-PKGD, Part Number 474171

Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Code Information Lot/Serial Numbers: All
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The recall was initiated because Beckman Coulter has confirmed that the Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results.
FDA Determined
Cause 2		 Component design/selection
Action Beckman Coulter sent an URGENT: Product Corrective Action letter to all affected customers. The letter provided customers with an explanation of the problem identified and actions to be taken. The letter instructs customers to share this information with their laboratory staff and retain a copy as part of their laboratory Quality System documentation. In addition, the letter states that if the affected product was further distributed to provide a copy of the letter to them. Customers were also asked to complete and return the enclosed Response Form. For any questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.
Quantity in Commerce 3278 total (3083 in US, 195 in Canada)
Distribution Worldwide Distribution - USA (nationwide) and the country of 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.
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