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.
What this means for you
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 HORI
- 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.
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