Tosoh Bioscience Inc recalls

72 recalls on record · latest: August 7, 2020

Official U.S. recall history for Tosoh Bioscience Inc, compiled from official government records.

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Tosoh Bioscience Inc recalls Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 02…

August 7, 2020 · Medical device recalls Moderate risk Decreased stability for five (5) lots of Calibrator Sets and Calibration Verifi…

Tosoh Bioscience Inc recalls Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibra…

August 7, 2020 · Medical device recalls Moderate risk Decreased stability for five (5) lots of Calibrator Sets and Calibration Verifi…

Tosoh Bioscience Inc recalls AIA-900 Analyzer, Part no. 022930, UDI 04560189283992

May 22, 2020 · Medical device recalls Moderate risk The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty…

Tosoh Bioscience Inc recalls AIA-360 Automated Immunoassay Analyzer, Product Code 019945

January 10, 2020 · Medical device recalls Moderate risk A display screen software issue on the analyzer causes the display to freeze wh…

Tosoh Bioscience Inc recalls ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative…

November 30, 2018 · Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human…

November 30, 2018 · Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocys…

November 30, 2018 · Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testost…

November 30, 2018 · Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurem…

November 30, 2018 · Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12…

November 30, 2018 · Medical device recalls Moderate risk Potential for fluorescein interference to cause inaccurately elevated results f…

Tosoh Bioscience Inc recalls AIA-900 Analyzer, Product code 022930, 022930R

October 5, 2018 · Medical device recalls Moderate risk Tosoh Bioscience has become aware of a potential issue with the pickup arm and…

Tosoh Bioscience Inc recalls AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performin…

October 5, 2018 · Medical device recalls Moderate risk Tosoh Bioscience has become aware of a potential issue with the axis base of th…

Tosoh Bioscience Inc recalls Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory test…

October 5, 2018 · Medical device recalls Tosoh Bioscience has become aware of potential degradation of HbA1c control lot…

Tosoh Bioscience Inc recalls AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three metho…

September 28, 2018 · Medical device recalls Moderate risk There is a possibility that the liquid suction pump on some AIA-2000 analyzers…

Tosoh Bioscience Inc recalls Tosoh AIA-900 immunoassay Analyzer

September 28, 2018 · Medical device recalls Moderate risk A software issue may cause the liquid volume detection entries for 2nd and 3rd…

Tosoh Bioscience Inc recalls AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable…

September 28, 2018 · Medical device recalls Moderate risk Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA…

Tosoh Bioscience Inc recalls AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing thre…

September 28, 2018 · Medical device recalls Moderate risk Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA…

Tosoh Bioscience Inc recalls AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diag…

August 23, 2018 · Medical device recalls Moderate risk The firm has implemented new product labeling changes for the Tosoh AIA-360 Ana…

Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemogl…

July 13, 2018 · Medical device recalls Moderate risk Analyzers were distributed with software which lacks a 510K

Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemo…

June 6, 2018 · Medical device recalls Moderate risk HbAE is known to interfere with the HbA1c assay on the current version of softw…

Tosoh Bioscience Inc recalls Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals fo…

June 5, 2018 · Medical device recalls Distribution of unapproved product labeling

Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for…

March 5, 2018 · Medical device recalls Moderate risk The assay can potentially generate erroneously elevated or erroneously decrease…

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 the…

March 5, 2018 · Medical device recalls Moderate risk The assay can potentially generate erroneously elevated or erroneously decrease…

Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Onl…

March 5, 2018 · Medical device recalls Moderate risk The assay can potentially generate erroneously elevated or erroneously decrease…

Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vit…

March 5, 2018 · Medical device recalls Moderate risk The assay can potentially generate erroneously elevated or erroneously decrease…