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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control Product Usage: Is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Recall Number Z-1436-2014
Classification Class II
Code Info Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
Product Distributed Qty 3,540
Reason For Recall Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

Event Detail

Event Id 67724
Product Type Devices
Status Ongoing
Recalling Firm Clinical Diagnostic Solutions
City Plantation
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.