CLASS III Device recall · Reported 28 Nov 2012 · FDA Enforcement Report

Minotrol 16, Model Numbers recalled by Horiba Instruments

Horiba Instruments is recalling Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, distributed nationwide in the US. The recall was initiated on 14 Sep 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).

Quantity recalled22,954

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0429-2013
FDA event ID: 63539
Recalling firm: Horiba Instruments, Irvine, CA
Classification: Class III
Status: Terminated
Recall initiated: 14 Sep 2012
FDA classified: 21 Nov 2012
Reported: 28 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: FAX
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

14 Sep 2012	Recall initiated by company
21 Nov 2012	Classified by FDA	+68 days
28 Nov 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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