Recall Z-1169-2018
Beckman Coulter Inc. · initiated January 19, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
Codes / lots: All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1169-2018
- Initiated
- January 19, 2018
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 98 units in the US
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA