Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for
FDA device recall Z-0291-2014 · posted 2013-11-14 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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.
- Date initiated
- 2013-09-12
- Date posted
- 2013-11-14
- Date terminated
- 2013-11-14
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823) | Bio-Rad Laboratories, Inc. | 1992-08-05 |