Z-2078-2011

UniCel DxC 800 The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical...

Name: Z-2078-2011 UniCel DxC 800 The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical...
Creator: Beckman Coulter Inc.
Published: 2010-10-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-10-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of UniCel DxC 800 The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro... on 2010-10-22. The reason FDA records is "This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2078-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2011-04-26
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC 800 The UniCel DxC SynchronClinical 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: CEM Electrode, Ion Specific, Potassium
Reason for recall: This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
Quantity in commerce: 4879 units total (3490 in US)
Distribution: Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
Product codes and lots: Part Number: A11816 Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP

Product code CEM

K042291Class IIUnicel Dxc 600 and 800 Synchron SystemsBeckman Coulter, Inc. / cleared 2004-11-12

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)