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Tosoh Bioscience Recalls
74 recalls on record · April 17, 2013 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 23, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In V
Hazard: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
May 23, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only fo
Hazard: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
May 23, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use O
Hazard: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
May 23, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for th
Hazard: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
March 7, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Hazard: 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.
March 7, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
Hazard: 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.
February 7, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tra
Hazard: 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.
February 7, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated
Hazard: 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.
June 7, 2017Medical DevicesFDA
Tosoh Bioscience, Inc. recalls AIA-PACK TgAb CONTROL SET
Hazard: 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.
June 7, 2017Medical DevicesFDA
Tosoh Bioscience, Inc. recalls AIA-PACK TPOAb CONTROL SET
Hazard: 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.
March 1, 2017Medical DevicesFDA
Tosoh Bioscience, Inc. recalls Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Hazard: 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%.
August 3, 2016Medical DevicesFDA
Tosoh Bioscience, Inc. recalls Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for
Hazard: Instructions For Use had incorrect lot number and calibrator values
July 22, 2015Medical DevicesFDA
Tosoh Bioscience, Inc. recalls G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product
Hazard: 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.
April 17, 2013Medical DevicesFDA
Tosoh Bioscience Inc recalls G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Hazard: 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 detected with the G7 Beta-thalessemia columns.