Z-0863-2010

Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600)...

Name: Z-0863-2010 Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600)...
Creator: Beckman Coulter Inc.
Published: 2010-01-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-01-04 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i)... on 2010-01-04. The reason FDA records is "Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0863-2010
Status: Terminated
Initiated: 2010-01-04
Posted: 2010-03-04
Terminated: 2012-04-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. Questions should be directed to the Customer Support Center at 1-800-854-3633.
Quantity in commerce: 2630
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).

Product code JJE

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)