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Horiba Instruments Recalls
9 recalls on record · December 31, 2014 to May 4, 2016 · Medical Devices
Recalls by year
14
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
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The recall feeds record what looks like the same company under more than one name:
May 4, 2016Medical DevicesFDA
Horiba Instruments Inc recalls Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyze
Hazard: 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.
May 4, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry anal
Hazard: 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.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid
Hazard: 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 method.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglyc
Hazard: 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 method.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of
Hazard: 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 method.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of
Hazard: 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 method.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determina
Hazard: 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 method.
February 10, 2016Medical DevicesFDA
Horiba Instruments Inc recalls The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholester
Hazard: 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 method.
December 31, 2014Medical DevicesFDA
Horiba Instruments Inc recalls Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite D
Hazard: 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 above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is