Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0429-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2012-09-14 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0429-2013
Date of alert: 2012-09-14
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Horiba Instruments, Inc dba Horiba Medical
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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