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Horiba Instruments, Inc dba Horiba Medical Recall: Minotrol 16, Model Numbers: 2043748, 20

Horiba Instruments, Inc dba Horiba Medical Recall: Minotrol 16, Model Numbers: 2043748, 20 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Horiba Instruments, Inc dba Horiba Medical; Product: Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal,

Recalling firmHoriba Instruments, Inc dba Horiba Medical
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
Reason for recallHORIBA 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.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionNationwide Distribution
Recall initiated20120914
Recall numberZ-0429-2013
Categorydevice
StateCA
CountryUnited States

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