UniCel DxI 600 Access Immunoassay Systems — Class II medical device recall Z-2258-2012
Terminated recall by Beckman Coulter Inc., reported 2012-08-29, distributed nationwide. The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniC
| Recall number | Z-2258-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2011-10-13 |
| Classified | 2012-08-23 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CN, CO, CZ, DE, DZ, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JP, KR, KW, MA, MX, MY, NL, NO, NZ, PH, PL, RO, SE, SG, SK, TH, TN, TR, TW, VE, VN, ZA |
| Reason classes | software |
| Model numbers | 600, A30260 |
Product
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Reason for recall
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Machine access
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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.