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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High). Class III 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. 22,954 Z-0429-2013
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