Recall Z-1436-2014
Clinical Diagnostic Solutions · initiated February 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
Reason for recall
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1436-2014
- Initiated
- February 24, 2013
- Posted by FDA
- April 9, 2014
- Terminated
- August 7, 2014
- Product code
- JPK – Mixture, Hematology Quality Control
- Quantity
- 3,540
- Distribution
- Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
- Recalling firm
- Clinical Diagnostic Solutions, Plantation, FL