FDAFDA · Food and drugs·Recall number Z-0291-2014
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.
Published November 20, 2013 · Recall initiated: September 12, 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
Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
- Lot
- Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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