FDAFDA · Food and drugs·Recall number Z-0429-2013
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
Published November 28, 2012 · Recall initiated: September 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- Nationwide Distribution
- Lot
- Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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