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Horiba Instruments, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Horiba Instruments, Inc. makes

Horiba Instruments, Inc. manufactures electrolyte analyzers, including models such as the SERA-210, SERA-252, and SERA-250, designed for measuring key ionic concentrations in blood and serum samples. These devices support clinical chemistry applications, particularly in hospital laboratories and point-of-care settings. The portfolio includes both standard and modified versions of the SERA-210 for tailored diagnostic use.

The company’s electrolyte analyzers fall under FDA Class II regulation and are listed via the 510(k) pathway. These devices are intended for use in the United States, where regulatory compliance is required for market authorization. No additional registries or classifications are specified for these products.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

  • Electrolyte Analyzer Sera-210 Ref K841424

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Electrolyte Analyzer Sera-252 Ref K853405

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modify Electrolyte Analyzer Model Sera-210 Ref K844806

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sera-250 Ref K841441

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Sera-210 Electrolyte Analyzer Ref K853356

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 9 recalls initiated by Horiba Instruments, Inc., the earliest on 2014-11-19 and the most recent on 2016-02-19. By recorded status: 9 terminated. The reasons filed fall into these groups: software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2016

    • 19 Feb 2016 Z-1553-2016 Class II Terminated 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. Distribution: USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID,…
      Full distribution text USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
    • 19 Feb 2016 Z-1554-2016 Class II Terminated 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. Distribution: USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID,…
      Full distribution text USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
    • 11 Jan 2016 Z-0738-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
      Submission number: K060854
    • 11 Jan 2016 Z-0739-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
      Submission number: K110137
    • 11 Jan 2016 Z-0740-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
      Submission number: K052007
    • 11 Jan 2016 Z-0741-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
    • 11 Jan 2016 Z-0742-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
      Submission number: K060854
    • 11 Jan 2016 Z-0743-2016 Class II Terminated 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. Distribution: U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID,…
      Full distribution text U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
      Submission number: K081276

  • 2014

    • 19 Nov 2014 Z-0856-2015 Class II Terminated 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 Distribution: Nationwide within the U.S.

Frequently asked questions

How many devices does Horiba Instruments, Inc. have in the registry?

The registry currently lists 5 devices for Horiba Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Horiba Instruments, Inc.'s devices?

Among its 5 most recently registered devices, Horiba Instruments, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Horiba Instruments, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Horiba Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Horiba Instruments, Inc.?

FDA recall records list 9 recalls initiated by Horiba Instruments, Inc., the most recent initiated on 19 Feb 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Horiba Instruments, Inc. in the registry?

The most recently registered devices listed for Horiba Instruments, Inc. include ELECTROLYTE ANALYZER SERA-210, ELECTROLYTE ANALYZER SERA-252, MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 and SERA-250.

Generated automatically from registry data and not verified by a human reviewer.