Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the p...
FDA Recall #Z-0193-2013 — Class III — August 4, 2010
Product Description
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.
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
Recalling Firm
Clinical Diagnostic Solutions — Plantation, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
532 packs
Distribution
Nationwide Distribution.
Code Information
Product part 501-605, Lot #1005-549
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated