Access 2 Immunoassay Systems — Class II medical device recall Z-0175-2015
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 Access 2 Immu
| Recall number | Z-0175-2015 |
|---|---|
| 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 | 386220, 81600N, B14253A |
Product
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 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
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.
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-0175-2015. 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.