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.
FDA Recall Z-1737-2014 · Posted 2014-06-09
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-05-14
Date Terminated2014-12-25
Product Quantity82 units
Reason for Recall
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were
potentially assembled with incorrect mounting screws.
Firm 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
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.