Access 2 Immunoassay System — Class II medical device recall Z-0291-2014
Terminated recall by Beckman Coulter Inc., reported 2013-11-20, distributed nationwide. Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the sys
| Recall number | Z-0291-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-09-12 |
| Classified | 2013-11-14 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2013-11-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, HK, KR |
| Serial numbers | 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810 |
| Model numbers | 81600N |
Product
Access 2 Immunoassay System, Part Number: 81600N 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 recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
Machine access
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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.