Z-0128-2012

SYNCHRON CX5 Delta Clinical System Part #: 468243

Name: Z-0128-2012 SYNCHRON CX5 Delta Clinical System Part #: 468243
Creator: Beckman Coulter Inc.
Published: 2010-08-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-23 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON CX5 Delta Clinical System Part #: 468243 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and... on 2010-08-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0128-2012
Status: Terminated
Initiated: 2010-08-23
Posted: 2011-10-27
Terminated: 2012-06-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON CX5 Delta Clinical System Part #: 468243 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
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 1070 systems total in US
Distribution: Worldwide Distribution - USA (nationwide) and the country of Canada
Product codes and lots: All non-PRO Software Versions

Product code JJE

K950958Class ISynchon Cx Delta Clin Syst (Cx4, Cx5, Cx7 Delta)Beckman Instruments, Inc. / cleared 1995-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)