Access Immunoassay Systems Assay Protocol: Dil-AFP.
FDA device recall Z-1388-05 · posted 2005-08-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.
- Action taken
- Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOJ
- Quantity affected
- 311 USA 16 Canada
- Distribution
- Nationwide and Canada
- Date initiated
- 2005-07-18
- Date posted
- 2005-08-23
- Date terminated
- 2012-03-07
- 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 AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (K981354) | Beckman Instruments, Inc. | 1998-05-01 |