Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to mo
FDA device recall Z-1436-2014 · posted 2014-04-09 · Terminated
Recall details
- Recalling firm
- Clinical Diagnostic Solutions
- Reason for recall
- Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
- Action taken
- Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 3,540
- Distribution
- Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
- Date initiated
- 2013-02-24
- Date posted
- 2014-04-09
- Date terminated
- 2014-08-07
- Location
- Plantation, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDS 3-PD HEMATOLOGY CONTROLS (K024173) | Clinical Diagnostic Solutions, Inc. | 2003-01-14 |