Access Immunoassay Systems Reaction Vessels — Class II medical device recall Z-0519-2014
Terminated recall by Beckman Coulter Inc., reported 2013-12-25, distributed nationwide. Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Aces
| Recall number | Z-0519-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-10-02 |
| Classified | 2013-12-16 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA, CN, CR, GT, HK, IN, JP, MX, PA, PH, SV, TH, TT, TW, VE, VN, ZA |
| Quantity | 16,154 units |
| Lot numbers | 13181168-13341170 |
| Model numbers | 81901 |
Product
Access Immunoassay Systems Reaction Vessels. 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
Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I
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-0519-2014. 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.