—#161071

Product

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

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2018-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.