Z-1375-2012

Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part...

Name: Z-1375-2012 Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part...
Creator: Beckman Coulter Inc.
Published: 2008-09-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-09-11 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number... on 2008-09-11. The reason FDA records is "The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay". 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-1375-2012
Status: Terminated
Initiated: 2008-09-11
Posted: 2012-04-06
Terminated: 2012-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number: A54379, UniCel DxC 600i AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.
Quantity in commerce: 2948 units total (2762 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: Part Number: A54378, UniCel DxC 600i APF, Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.

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)