AutoMate 1250 and AutoMate 2550 — Class II medical device recall Z-0056-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-24, distributed nationwide. The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being label
| Recall number | Z-0056-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-04-11 |
| Classified | 2012-10-12 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2013-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IE, IL, IN, IT, JP, KR, KW, MY, NL, NO, NZ, PA, SE, SI, SK, TR, ZA |
| Reason classes | labeling, software |
| Model numbers | ODL25125, ODL25255 |
Product
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 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 processes. 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 the 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
The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.
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-0056-2013. 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.