Horiba Medical Recalls Minotrol 16 Hematology Control Material
Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which by definition is unlikely to cause adverse health consequences. The issue is a performance deviation (high recovery values) in a diagnostic control, not a direct patient safety hazard.
Plain-English summary
Horiba Medical is recalling Minotrol 16, a tri-level control material intended for in vitro diagnostic use in monitoring the accuracy and precision of hematology blood cell counters. The recall affects Model Numbers 2043748, 2043752, and 2043756, specifically Lot Number MX090 (Level High). The product is composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives.
The recall was initiated after Horiba Medical Irvine Technical Support received reports from customers experiencing high recovery values for Hemoglobin when using the affected lot. Customer communication regarding this issue was sent on October 1, 2010.
The recall involves 22,954 units distributed nationwide. Users of the affected product should stop using the material and contact Horiba Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 22,954
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model Numbers: 2043748
- 2043752
- 2043756
- Lot Number: MX090(Levels Low
- Normal
- and High).
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Horiba Instruments, Inc dba Horiba Medical
See all →- ModerateHoriba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation
FDA (Devices) · 2018-07-04
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues
FDA (Devices) · 2015-01-14
- ModerateHoriba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update
FDA (Devices) · 2014-10-01
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighEurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05
- ModerateHoriba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values
FDA (Devices) · 2014-03-12
- SevereEurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05
- ModerateHoriba Medical Recalls ABX PENTRA N Control for Revised Potassium Values
FDA (Devices) · 2014-02-12
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues
FDA (Devices) · 2018-02-07