Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
FDA device recall Z-1148-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Defective software media distributed with upgrade software may cause installation failure and systems lock.
- Action taken
- Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLS
- Quantity affected
- 1615
- Distribution
- United States only, nationwide.
- Date initiated
- 2003-06-18
- Date posted
- 2003-08-21
- Date terminated
- 2004-04-20
- 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 |