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Completed

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

FDA Recall Z-1169-2018 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusCompleted
Product CodeJQP
Date Initiated2018-01-19
Product Quantity98 units in the US

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.

Firm Action

Beckman Coulter plans to replace the belt via Service Modification during the next planned service maintenance visit. At that time, the customer will be informed of the belt replacement by the service engineer.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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