Tosoh Bioscience recalls

Tosoh Bioscience appears in 74 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• ST-AIA PACK TU
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK Estradiol
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK CK-MB
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK Fer
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK SHBG
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK CEA
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK LH II
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK FT4
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK FSH
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• ST-AIA PACK HCG
  FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
  Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
• Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use On…
  FDA Device · Class II · 2018-05-23 · Tosoh Bioscience
  Reason: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
• Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibratio…
  FDA Device · Class II · 2018-05-23 · Tosoh Bioscience
  Reason: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
• Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality c…
  FDA Device · Class II · 2018-05-23 · Tosoh Bioscience
  Reason: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
• Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measure…
  FDA Device · Class II · 2018-05-23 · Tosoh Bioscience
  Reason: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
• ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
  FDA Device · Class II · 2018-03-07 · Tosoh Bioscience
  Reason: 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.
• ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
  FDA Device · Class II · 2018-03-07 · Tosoh Bioscience
  Reason: 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.
• Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932
  FDA Device · Class II · 2018-02-07 · Tosoh Bioscience
  Reason: 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.
• Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930
  FDA Device · Class II · 2018-02-07 · Tosoh Bioscience
  Reason: 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.
• AIA-PACK TgAb CONTROL SET
  FDA Device · Class III · 2017-06-07 · Tosoh Bioscience
  Reason: 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 inclu…
• AIA-PACK TPOAb CONTROL SET
  FDA Device · Class III · 2017-06-07 · Tosoh Bioscience
  Reason: 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 inclu…
• Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing
  FDA Device · Class II · 2017-03-01 · Tosoh Bioscience
  Reason: 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…
• Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package
  FDA Device · Class III · 2016-08-03 · Tosoh Bioscience
  Reason: Instructions For Use had incorrect lot number and calibrator values
• G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elut…
  FDA Device · Class III · 2015-07-22 · Tosoh Bioscience
  Reason: 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.
• G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood
  FDA Device · Class III · 2013-04-17 · Tosoh Bioscience
  Reason: 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. Th…