Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot… recallZ-0429-2013 · Horiba Instruments, Inc dba Horiba Medical · initiated Sep 14, 2012
Class III Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horiba Instruments, Inc dba Horiba Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0429-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Sep 14, 2012
- Posted by the FDA
- Nov 21, 2012
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 22,954
- Product code
- JPK
- FDA submissions
- K843962, K850755
- Distribution
- Nationwide Distribution
Product description
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
Code information (models, lots, serial numbers)
Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
Other devices under the same FDA submission
1 device cleared under K843962, K850755 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® 360 Control 11170853Siemens Healthcare Diagnostics Inc. · MIXTURE, HEMATOLOGY QUALITY CONTROL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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