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Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parame
Recalled November 14, 2012 · FDA recall Z-0191-2013 · Clinical Diagnostic Solutions
Hazard
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai · FDA Class III
Units
197 vials
Sold at
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
Description
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Product
Boule Con-Diff Hematology Control 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 →