Home / Recalls / Medical Devices
Clinical Diagnostic Solutions recalls Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to m
Recalled April 16, 2014 · FDA recall Z-1436-2014 · Clinical Diagnostic Solutions
Hazard
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. · FDA Class II
Units
3,540
Sold at
Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Description
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
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.
Manufacturer(s)
Clinical Diagnostic Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →