FDA Device recall Z-0492-2020
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106
- FDA Device
- Class II
- ongoing
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106 by Beckman Coulter, citing beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0492-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-09 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | NY, VA |
Product
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Reason
Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .
Identifiers
| code_info | All units containing software Version(s) 4.1.1 and up |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0492-2020%22
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