IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
FDA device recall Z-0884-05 · posted 2005-06-11 · Terminated
Recall details
- Recalling firm
- International Remote Imaging Systems Inc
- Reason for recall
- Nonconformance to performance specifications.
- Action taken
- Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJW
- Quantity affected
- 107
- Distribution
- Nationwide.
- Date initiated
- 2005-04-29
- Date posted
- 2005-06-11
- Date terminated
- 2012-05-07
- Location
- Chatsworth, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRISPEC URINE CHEMISTRY CONTROL PART A AND B (K945913) | International Remote Imaging Systems | 1995-04-05 |