Access 2 Immunoassay System Analyzer — Class II medical device recall Z-0984-2014
Terminated recall by Beckman Coulter Inc., reported 2014-02-26, distributed in SD. The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-con
| Recall number | Z-0984-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-11-26 |
| Classified | 2014-02-16 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-07-27 |
| Distributed | SD |
| Countries outside the US | CN, DE, LB |
| Quantity | 3 units |
| Serial numbers | 508957, 508963, 508964 |
| Model numbers | 81600N |
Product
Access 2 Immunoassay System Analyzer. The Access 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 Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
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-0984-2014. 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.