PlainRecalls

Horiba Instruments, Inc dba Horiba Medical

Compiled from official public sources by the publisher.

17 recalls on record · Latest: Jul 4, 2018

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Agency notice ledger

Federal filing book Horiba Instruments, Inc dba… LIGHT-BOOK · SINGLE-AGENCY

#931 of 14,151 · 17 notices · 0.016% archive

  • BOOK 17 notices
  • RANK #931 of 14,151
  • SHARE 0.016% archive
  • AGENCY FDA Devices (17)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 4, 2018
  • PHOTO Actavis Inc

Nearest notice-volume peer: Actavis Inc (0 notice gap)

Horiba Instruments, Inc dba Horiba Medical accounts for about 0.016% of the 104,423-notice archive on 17 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Horiba Instruments, Inc dba…'s standing among 14,151 recalling firms

Horiba Instruments, Inc dba Horiba Medical ranks 931st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Horiba Instruments, Inc dba… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

17 931st of 14151 higher than 13,196 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Horiba Instruments, Inc dba… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Horiba Instruments, Inc dba Horiba Medical holds about 0.016% of archive notices alongside 17 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 variety of analytes.
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 for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
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. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
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 two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on t
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 quantitative methods as specified in the enclosed annex.
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 prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial o
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 glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calci
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 to measure absorbance and ion electrodes.
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, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
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 Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
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 potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
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 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 prov
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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calib

Horiba Instruments, Inc dba… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ad-Tech Medical Instrument Corporation 17 Fhc, Inc. 17 Ge Healthcare It 17 Hitachi Medical Systems America Inc 17

Frequently Asked Questions

How many federal recall notices name Horiba Instruments, Inc dba…? ▼
PlainRecalls indexes 17 distinct federal recall events naming Horiba Instruments, Inc dba Horiba Medical, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Horiba Instruments, Inc dba… sit among other recalling firms? ▼
Horiba Instruments, Inc dba Horiba Medical ranks #931 of 14,151 by distinct recall-event count among 14,151 firms in this archive (93rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Horiba Instruments, Inc dba…'s notices? ▼
FDA Devices accounts for 17 of this firm's 17 indexed notices.
What product category dominates Horiba Instruments, Inc dba…'s filing book? ▼
Filings for Horiba Instruments, Inc dba Horiba Medical span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Horiba Instruments, Inc dba Horiba Medical: 17 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Horiba Instruments, Inc dba Horiba Medical; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026