Z-0429-2013Class III

Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High)...

Name: Z-0429-2013 Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High)...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2012-09-14
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-09-14 / Terminated / root cause: manufacturing process

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of 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... on 2012-09-14. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0429-2013
Classification: Class III
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-11-21
Terminated: 2013-04-22
Recalling firm: Horiba Instruments Incorporated
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 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
Product code: JPK Mixture, Hematology Quality Control
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: HORIBA Medical sent a Product Information Notice letter dated November 5, 2010 via Fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instructions included with the Product Information Notice. For questions customers were instructed to call the Technical Support Hotline at 1-888-903-5001. For questions regarding this recall call 949-453-0500, ext 208.
Quantity in commerce: 22,954
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0429-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0429-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code JPK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)