Recall Z-1169-2018 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc.
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
| Date | Jan 19, 2018 |
| Status | Completed |
| Reason | 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 | Device Design |
| 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. |
| 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 Ze |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.