RegWardenFDA facility compliance records
Facility

TOSOH BIOSCIENCE, INC.

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

Activity by year

FDA actions on record by year2010: 1 recalls; 2012: 1 recalls; 2015: 1 recalls; 2016: 2 recalls, 1 inspections, 1 warning letters; 2017: 4 recalls; 2018: 14 recalls, 1 inspections; 2019: 1 inspections; 2020: 3 recalls; 2026: 1 recalls1’10’111’12’13’141’154’164’1715’181’193’20’21’22’23’24’251’26
  • Recalls (27)
  • Inspections (3)
  • Warning letters (1)

Devices registered here (1)

  • Radioimmunoassay, Total Triiodothyronine
    Product code CDP (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1710

Recalls & enforcement

20261 record
  • Class IIOngoing2026-06-12
    The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testi…
20203 records
  • Class IITerminated2020-08-07
    Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
  • Class IITerminated2020-05-22
    The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
  • Class IITerminated2020-01-10
    A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
201814 records
  • Class IITerminated2018-11-30
  • Class IITerminated2018-10-05
    Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a de…
  • Class IITerminated2018-10-05
    Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase…
  • Class IIITerminated2018-10-05
    Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may res…
  • Class IITerminated2018-09-28
    Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that wil…
  • Class IITerminated2018-09-28
    A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. Th…
  • Class IITerminated2018-09-28
    There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the…
  • Class IITerminated2018-08-23
    The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Re…
  • Class IITerminated2018-07-13
    Analyzers were distributed with software which lacks a 510K
  • Class IITerminated2018-06-06
    HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
  • Class IIITerminated2018-06-05
    Distribution of unapproved product labeling
  • Class IITerminated2018-03-05
    The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
  • Class IITerminated2018-03-05
    Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
  • Class IITerminated2018-02-13
    Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
20174 records
  • Class IITerminated2017-09-28
    The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature we…
  • Class IITerminated2017-06-11
    This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
  • Class IITerminated2017-03-22
    The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sen…
  • Class IIITerminated2017-02-08
    The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
20162 records
  • Class IITerminated2016-11-07
    The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
  • Class IIITerminated2016-06-07
    Instructions For Use had incorrect lot number and calibrator values
20151 record
  • Class IIITerminated2015-02-10
    The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
20121 record
  • Class IITerminated2012-02-23
    Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
20101 record
  • Class IIITerminated2010-08-18
    The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be det…

FDA inspections (3)

  • VAI2019-10-11
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • NAI2018-10-16
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2016-06-28
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “TOSOH BIOSCIENCE, INC. (FEI 3005529799) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005529799-tosoh-bioscience-inc/

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