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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Boule Con-Diff Hematology Control		see related information
Date Posted November 05, 2012
Recall Number Z-0193-2013
Product Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Information Product part 501-605, Lot #1005-549
Recalling Firm/
Manufacturer		 Clinical Diagnostic Solutions
1800 Nw 65th Ave Ste 2
Plantation, Florida 33313-4544
For Additional Information Contact Maritza Pastoriza
954-791-1773
Reason for
Recall		 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
Action Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.
Quantity in Commerce 532 packs
Distribution Nationwide Distribution.
 
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