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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

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.
Recall Number Z-0193-2013
Classification Class III
Code Info Product part 501-605, Lot #1005-549
Product Distributed Qty 532 packs
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 Con-Diff Tri pack Lot 1005-549 were low and out of the assay range.

Event Detail

Event Id 63094
Product Type Devices
Status Ongoing
Recalling Firm Clinical Diagnostic Solutions
City Plantation
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-08-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.
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