Z-0123-2013Class II

UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are...

Name: Z-0123-2013 UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are...
Creator: Beckman Coulter Inc.
Published: 2012-09-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-09-03 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical... on 2012-09-03. FDA classified it as Class II and gives the reason as "Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader...". 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-0123-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-03
Posted: 2012-10-24
Terminated: 2014-02-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled 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 has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar
Root cause tag: software
FDA root cause: Software change control
Action: Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call 714-993-5321.
Quantity in commerce: 7 units total (both US and International)
Distribution: Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey
Product codes and lots: Part Number B12218. Serial numbers 2329, 5477, 5479.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

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)