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U.S. Department of Health and Human Services

Class 3 Device Recall Minotrol 16

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 Class 3 Recall
Minotrol 16
see related information
Date Posted November 21, 2012
Recall Status1 Terminated on April 22, 2013
Recall Number Z-0429-2013
Recall Event ID 63539
Premarket Notification
510(K) Numbers
K843962  K850755 
Product Classification Mixture, Hematology Quality Control - Product Code JPK
Product 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
Code Information Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
Recalling Firm/
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine, California 92618-4210
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action HORIBA Medical sent a Product Information Notice letter dated November 5, 2010 via Fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instructions included with the Product Information Notice. For questions customers were instructed to call the Technical Support Hotline at 1-888-903-5001. For questions regarding this recall call 949-453-0500, ext 208.
Quantity in Commerce 22,954
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JPK and Original Applicant = R & D SYSTEMS, INC.
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