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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmSeptember 14, 2012
Create DateNovember 21, 2012
Recall Status1 Terminated 3
Recall NumberZ-0429-2013
Recall Event ID 63539
ProductMinotrol 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
Recalling Firm/
Manufacturer		 Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact
949-453-0500 Ext. 208
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.
ActionHORIBA 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 Commerce22,954
DistributionNationwide Distribution
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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