Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
FDA device recall Z-0536-2007 · posted 2007-02-27 · Terminated
Recall details
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Reason for recall
- Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
- Action taken
- Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 38 kits
- Distribution
- Nationwide.
- Date initiated
- 2006-09-06
- Date posted
- 2007-02-27
- Date terminated
- 2007-05-14
- Location
- Charlottetown Canada, Prince Edward Island
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROALBUMIN MULTI-CALIBRATOR SET (K042243) | Diagnostic Chemicals , Ltd. | 2004-10-04 |