Recall Z-1169-2018— Beckman Coulter Inc.

Name: FDA recall Z-1169-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Class II · Completed

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-01-19. FDA's recall record names no specific 510(k) clearance for this event. Product: AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255. Reason: Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Completed
Initiated: 2018-01-19
Firm location: Brea, CA, United States

Product description

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

Reason for recall

Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.

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