FDA Device recall Z-1040-2017
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550
- FDA Device
- Class III
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class III recall of AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550 by Beckman Coulter, citing beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1040-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-21 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | MD |
Product
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 tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
Reason
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Identifiers
| code_info | ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1040-2017%22
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