Z-1737-2014Class II

Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems. The Access Family of...

Name: Z-1737-2014 Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of...
Creator: Beckman Coulter Inc.
Published: 2014-05-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-14 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI... on 2014-05-14. FDA classified it as Class II and gives the reason as "Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1737-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-14
Posted: 2014-06-09
Terminated: 2014-12-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
FDA root cause: Mixed-up of materials/components
Action: Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 8, 2014 via first class mail. The letter identified the reason for recall, product information, issue, impact, action, resolution, contact information, and customer response form. Customers are advised to review historical quality control (QC) data and System Check results, and determine whether a review of patient test results is warranted. For questions regarding this letter, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com/customersupport/support, By phone: call 1-800-854-3633 in the United States and Canada, and Outside the United States and Canada, contact your local Beckman Coulter representative
Quantity in commerce: 82 units
Distribution: Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
Product codes and lots: Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1737-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1737-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code JJE

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