FDA recall Z-1169-2018

Beckman Coulter Inc. · Class II · device

Product

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.

Distribution

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, Lithuania, Macao, Mayotte, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Key facts

Status: Completed
Initiation date: 2018-01-19
Report date: 2018-03-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2018