FDAFDA · Food and drugs·Recall number Z-0984-2014
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.
Published February 26, 2014 · Recall initiated: November 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
- Lot
- Part Number 81600N. Serial Numbers 508957, 508963, 508964.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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