AutoMate 1250 — Class II medical device recall Z-0492-2020
Ongoing recall by Beckman Coulter Inc., reported 2019-11-27, distributed in NY, VA. Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting
| Recall number | Z-0492-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-11-09 |
| Classified | 2019-11-18 |
| Reported by FDA | 2019-11-27 |
| Distributed | NY, VA |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, IL, IT, LT, RO, SE, SK, ZA |
| Quantity | 83 automate |
| UPC / GTIN / UDI-DI | 15099590364083, 15099590364106 |
| Model numbers | ODL25125, ODL25255 |
Product
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Reason for recall
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) .
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-0492-2020. 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.