Medical device recalls Moderate risk

Beckman Coulter Inc. recalls AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyze…

Recall date
January 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1151-2018
FDA classification
Class II
Brand / firm
Beckman Coulter Inc.
Sold / distributed
Worldwide distribution. US nationwide, Algeria, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithu…

Why it was recalled

A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

Get recall alerts

Free email alert whenever Beckman Coulter Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Beckman Coulter Inc.