Access 2 Immunoassay System
FDA device recall Z-0692-03 · posted 2003-03-29 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- False results from secondary pour off tubes
- Action taken
- Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 718
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-01-30
- Date posted
- 2003-03-29
- Date terminated
- 2004-06-01
- 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 |