Z-0519-2014Class II

Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device...

Name: Z-0519-2014 Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device...
Creator: Beckman Coulter Inc.
Published: 2013-10-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-10-02 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or... on 2013-10-02. FDA classified it as Class II and gives the reason as "Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0519-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-02
Posted: 2013-12-16
Terminated: 2014-10-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I
FDA root cause: Pending
Action: Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.
Quantity in commerce: 16,154 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
Product codes and lots: Part Number 81901, Lot Numbers: 13181168-13341170.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0519-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0519-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-16

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)