Recall Z-1040-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc.
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the
| Date | Jan 18, 2017 (initiated Dec 21, 2016) |
| Status | Terminated |
| Reason | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10. |
| Root cause | Under Investigation by firm |
| Action | The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification. If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: RegulatoryAgencyInquiries@beckman.com. |
| Quantity | 4 units |
| Distribution | US Distribution to MD only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.