SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and C

FDA device recall Z-0125-2012 · posted 2011-10-27 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

Beckman 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.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

1070 systems in total in US

Distribution

Worldwide Distribution - USA (nationwide) and the country of Canada

Date initiated

2010-08-23

Date posted

2011-10-27

Date terminated

2012-06-28

Location

Brea, CA

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