Recall Z-1436-2014 ยท JPK Mixture, Hematology Quality Control
Clinical Diagnostic Solutions
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
| Date | Apr 9, 2014 (initiated Feb 24, 2013) |
| Status | Terminated |
| Reason | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 3,540 |
| Distribution | Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS Clinical Diagnostic Solutions, Inc., Jan 14, 2003 |