Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quanti
FDA device recall Z-0984-2014 · posted 2014-02-16 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 3 units
- Distribution
- Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
- Date initiated
- 2013-11-26
- Date posted
- 2014-02-16
- Date terminated
- 2014-07-27
- 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 |