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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents
Recall Number Z-0429-2013
Classification Class III
Code Info Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
Product Distributed Qty 22,954
Reason For Recall HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.

Event Detail

Event Id 63539
Product Type Devices
Status Ongoing
Recalling Firm Horiba Instruments, Inc dba Horiba Medical
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-14
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Nationwide Distribution
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