FDA-Device2014-04-16Class II
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.
Clinical Diagnostic Solutions
Hazard
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Sold states
Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Affected count
3,540
Manufactured in
1800 Nw 65th Ave Ste 2, N/A, Plantation, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1436-2014Don't want to check this manually?
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