UniCel DxC 600i SYNCHRON Access Clinical Analyzer — Class II medical device recall Z-0176-2015
Terminated recall by Beckman Coulter Inc., reported 2014-11-12, distributed nationwide. Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i anal
| Recall number | Z-0176-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2014-11-05 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BG, CA, CH, CN, CO, CR, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JP, KE, KR, LB, LK, MA, MX, MY, PA, PE, PH, PK, PL, PT, RO, RS, SA, SE, SK, SV, TH, TN, TR, TW, VE, VN, ZA |
| Serial numbers | 403732, 500039, 500061, 500117, 500143, 500172, 500231, 500300, 500335, 500350, 500357, 500360, 500402, 500403, 500425, 500436, 500478, 500480, 500484, 500490, 500494, 500507, 500530, 500531, 500533 and 475 more |
| Model numbers | A25640, A93659AB |
Product
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Reason for recall
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.
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.