FDA-Device2012-11-14Class III
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
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
Sold states
Nationwide Distribution.
Affected count
690 packs
Manufactured in
1800 Nw 65th Ave Ste 2, N/A, Plantation, FL, United States
Products
Boule Con-Diff Hematology Control 9 vials. 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-0194-2013Don't want to check this manually?
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