Recall Z-0291-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
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.
| Date | Nov 14, 2013 (initiated Sep 12, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | A phone call was made on 9/12/13 to customer who received the Access 2 System. The phone script explains the problem identified of a possible wrong fuse and may result in failure of the fuse to operate properly. Customer was instructed that their Field Service Engineer, will call them back the following week to check on their system and replace the fuses if necessary. If you have any questions concerning this information, please call 952-393-8546. |
| Quantity | 8 units total (1 unit in the US) |
| Distribution | Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc., Aug 5, 1992 |