Recall Z-1737-2014— Beckman Coulter Inc.

Name: FDA recall Z-1737-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-14

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2014-05-14, terminated 2014-12-25. It names one FDA 510(k) clearance: K042291. 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.. Reason: Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-14
Terminated: 2014-12-25
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042291 — UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc.·cleared 2004-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.

Data sourced from openFDA. This site is unofficial and independent of the FDA.