PlainRecalls

Horiba Instruments, Inc dba Horiba Medical

Compiled from official public sources by the editorial team.

17 recalls on record · Latest: Jul 4, 2018

Horiba Instruments, Inc dba Horiba Medical Recall Insight

Horiba Instruments, Inc dba Horiba Medical appears on 17 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.017% 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 17 entries, severity tagging shows 0 critical, 12 moderate, and 5 lower-severity recalls. Affected-unit counts are disclosed on 17 of 17 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 (17). 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 Feb 7, 2018

15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400

FDA Devices Moderate Jan 14, 2015

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

FDA Devices Moderate Oct 1, 2014

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are…

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 Mar 12, 2014

ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using tw…

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 Feb 12, 2014

ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepa…

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 Moderate Jan 9, 2013

ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspart…

FDA Devices Moderate Jan 9, 2013

PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiomet…

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…

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.