Z-2590-2010

UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The...

Name: Z-2590-2010 UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The...
Creator: Beckman Coulter Inc.
Published: 2010-02-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-25 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully... on 2010-02-25. The reason FDA records is "Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board)...". 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-2590-2010
Status: Terminated
Initiated: 2010-02-25
Posted: 2010-09-30
Terminated: 2012-07-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel 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)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
Root cause tag: software
FDA root cause: Other
Action: Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634
Quantity in commerce: 22
Distribution: Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
Product codes and lots: Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760

Product code JJE

K060256Class IIUnicel Dxc 600I Synchron Access Clinical SystemBeckman Coulter, Inc. / cleared 2006-02-27

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)