RegWardenFDA facility compliance records
Company

HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical

19 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 4 recalls; 2013: 5 recalls; 2014: 5 recalls; 2016: 2 recalls; 2017: 1 recalls; 2018: 2 recalls4’125’135’14’152’161’172’18’19’20’21’22’23’24’25’26
  • Recalls (19)

Registered facilities (2)

Recalls & enforcement

20182 records
  • Class IITerminated2018-10-30
    Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferen…
  • Class IITerminated2018-04-26
    When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sam…
20171 record
  • Class IITerminated2017-11-21
    The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
20162 records
  • Class IITerminated2016-02-19
    Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
  • Class IITerminated2016-01-11
    N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction m…
20145 records
  • Class IITerminated2014-11-19
    HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions abo…
  • Class IITerminated2014-11-13
    HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without…
  • Class IITerminated2014-08-11
    Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stabili…
  • Class IITerminated2014-02-14
    HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
  • Class IITerminated2014-01-20
    HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Cre…
20135 records
  • Class IIITerminated2013-12-18
    HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revise…
  • Class IITerminated2013-11-21
    Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
  • Class IIITerminated2013-09-06
    HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
  • Class IITerminated2013-03-20
    HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags…
  • Class IIITerminated2013-02-15
    Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
20124 records
  • Class IITerminated2012-10-10
    Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without a…
  • Class IITerminated2012-09-20
    Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient t…
  • Class IIITerminated2012-09-14
    This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.
  • Class IIITerminated2012-09-14
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10083022-horiba-instruments-incorporated-dba-hori/

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