AutoMate 2500 Family Catalog No — Class III medical device recall Z-1040-2017
Terminated recall by Beckman Coulter Inc., reported 2017-01-25. Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system
| Recall number | Z-1040-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-05-17 |
| Quantity | 4 units |
| Model numbers | ODL25120 |
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 for recall
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1040-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.