PlainRecalls

Horiba Instruments, Inc dba Horiba Medical

10 recalls on record · Latest: Jul 4, 2018

Horiba Instruments, Inc dba Horiba Medical Recall Insight

Horiba Instruments, Inc dba Horiba Medical appears on 10 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.012% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 4, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 10 entries, severity tagging shows 0 critical, 6 moderate, and 4 lower-severity recalls. Affected-unit counts are disclosed on 10 of 10 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (10). The date window on this page runs from Nov 21, 2012 to Jul 4, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 4, 2018

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a va…

FDA Devices Moderate Feb 7, 2018

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

FDA Devices Moderate Mar 19, 2014

Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. …

FDA Devices Moderate Feb 12, 2014

ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quan…

FDA Devices Low Oct 2, 2013

ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and…

FDA Devices Moderate Apr 24, 2013

HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used…

FDA Devices Low Apr 10, 2013

ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyb…

FDA Devices Moderate Jan 16, 2013

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

FDA Devices Low Nov 28, 2012

Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intend…

FDA Devices Low Nov 21, 2012

ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Cre…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds