Device 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.
Z-0291-2014
Product summary
- Event
- Event 66397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units total (1 unit in the US)
- Official record key
device-enforcement:Z-0291-2014
Official wording
Reason: Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
Code information: Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810
Distribution pattern: Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Derived failure modes
-
Unknown
Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.