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Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of mul
Recalled November 14, 2012 · FDA recall Z-0194-2013 · Clinical Diagnostic Solutions
Hazard
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule · FDA Class III
Units
690 packs
Sold at
Nationwide Distribution.
Description
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
Product
Boule Con-Diff Hematology Control 9 vials. 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 →