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.
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