Access 2 assay Immunoassay System — Class II medical device recall Z-1710-2017
Terminated recall by Beckman Coulter Inc., reported 2017-04-12, distributed in PR. Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls
| Recall number | Z-1710-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-03-07 |
| Classified | 2017-04-04 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-03-01 |
| Distributed | PR |
| Countries outside the US | AT, AU, BD, BG, BR, CA, CH, CN, CO, CR, CY, CZ, DE, DZ, ES, FR, GB, GH, GR, GT, ID, IN, IT, JO, JP, KE, KR, LB, LT, MA, MX, NP, OM, PA, PH, PK, PL, PY, RO, RS, SA, SV, TN, TR, VN, ZA |
| Serial numbers | 501012, 501110, 501190, 501224, 501294, 501371, 501394, 501403, 501440, 501443, 501490, 501501, 501673, 501681, 501693, 501861, 501920, 501926, 501936, 501970, 502165, 502196, 502319, 502331, 502332 and 108 more |
| Model numbers | 386220 |
Product
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices 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 Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
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-1710-2017. 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.