The Recall Desk

Manufacturer

Horiba Instruments, Inc dba Horiba Medical

17 recalls in our database name Horiba Instruments, Inc dba Horiba Medical as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2018-07-04

Of the 17 recalls from Horiba Instruments, Inc dba Horiba Medical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • ModerateFDA (Devices)·Z-2286-2018·2018-07-04

    Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation

    Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues

    Horiba Medical is recalling ABX PENTRA reagent cups that may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues

    Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2015·2015-01-14

    Horiba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues

    Horiba Medical is recalling ABX PENTRA Reagent Containers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2692-2014·2014-10-01

    Horiba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update

    Horiba Medical is recalling ABX PENTRA Magnesium RTU Reagent to update on-board stability claims from 7 days to 1 day.

    Product
    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 xylidy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2014·2014-03-19

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Transmission Bug

    Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2014·2014-03-12

    Horiba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values

    Horiba Medical is recalling ABX PENTRA calibrators and controls because target values for the Creatinine Rate Blank Method were updated.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0904-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA N Control for Revised Potassium Values

    Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0924-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA Urine Control L/H for Creatinine Range Update

    Horiba Medical is recalling ABX PENTRA Urine Control L/H because the target range for the Creatinine assay was updated. The recall affects 531 units distributed in the US and Canada.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2280-2013·2013-10-02

    Horiba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results

    Horiba Medical is recalling ABX PENTRA Calcium CP Reagent because it may report incorrect calcium results on PENTRA 200 and 400 analyzers.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1141-2013·2013-04-24

    Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags

    Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2013·2013-04-10

    Horiba Medical Recalls ABX Micros IM2 Data Management System

    Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

    Product
    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 v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2013·2013-01-16

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Validation Error

    Horiba Medical is recalling ABX PENTRA ML software versions V8.0.x and below, V9.0.1, and V9.0.2 because a rare data management issue may transmit incorrect patient results to the Laboratory Information System.

    Product
    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2013·2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    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 urin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2013·2013-01-09

    Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent

    Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0429-2013·2012-11-28

    Horiba Medical Recalls Minotrol 16 Hematology Control Material

    Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.

    Product
    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 HORI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0289-2013·2012-11-21

    Horiba Medical Recalls ABX PENTRA Creatinine 120 CP Reagent

    Horiba Medical is recalling ABX PENTRA Creatinine 120 CP reagent because a calibration alarm prevents the assay from being used.

    Product
    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 ba
    Category
    Medical Device
    Distribution
    Distributed nationwide