AutoMate 2550 "High Speed" Catalog Number ODL25255 — Class II medical device recall Z-1151-2018
Terminated recall by Beckman Coulter Inc., reported 2018-03-28, distributed nationwide. A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip er
| Recall number | Z-1151-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-01-18 |
| Classified | 2018-03-21 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CY, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, KR, KW, LT, LV, NL, NO, NZ, PA, PL, PT, RU, SA, SE, SI, SK, TR, TW, ZA |
| Quantity | 73 units |
| Serial numbers | 1048, 1049, 1054, 1055, 1107, 1147, 1251, 4025, 4048, 4052, 4055, 4072, 4073, 4074, 4076, 4079, 4091, 4097, 4107, 4111, 4126, 4127, 4141, 4143, 4144 and 48 more |
| Model numbers | ODL25125, ODL25255 |
Product
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
Reason for recall
A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.
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-1151-2018. 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.