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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON CX4

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 Class 2 Device Recall SYNCHRON CX4see related information
Date Initiated by FirmAugust 23, 2010
Date PostedOctober 27, 2011
Recall Status1 Terminated 3 on June 28, 2012
Recall NumberZ-0124-2012
Recall Event ID 59147
510(K)NumberK881498 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductSYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine
Code Information All non-PRO Software Versions
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92822-6232
For Additional Information ContactClair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
FDA Determined
Cause 2
Software design
ActionBeckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 20, 2010 with an attached Fax Back Response Form (via US Postal Service for US Customers) to all customers who purchased the Synchron CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems. The letter provides the customers wtih an explanation of the problem identified and actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected product listed above to another laboratory, they were asked to provide a copy of this letter to them. Questions regarding this Product Corrective Action letter, were directed to 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. Outside the United States and Canada, they were directed to their local Beckman Coulter Representative.
Quantity in Commerce1070 systems total in US
DistributionWorldwide Distribution - USA (nationwide) and the country of 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 = JJE
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