Access Immunoassay System — Class II medical device recall Z-0612-2013
Terminated recall by Beckman Coulter Inc., reported 2013-01-02, distributed nationwide. It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mi
| Recall number | Z-0612-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-11-01 |
| Classified | 2012-12-22 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2013-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6,858 units |
Product
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. 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. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
Reason for recall
It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
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-0612-2013. 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.