ACL Advance Instrument Analyzer
FDA device recall Z-0737-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Software may cause instrument to omit step causing reagent carrover which may effect patient test result
- Action taken
- Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 760 units
- Distribution
- Florida Canada
- Date initiated
- 2004-03-04
- Date posted
- 2004-07-20
- Date terminated
- 2016-01-28
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION OF ACL ADVANCE (K002400) | Instrumentation Laboratory CO | 2000-08-30 |