Tosoh Bioscience Inc: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Agency Publication Date: May 14, 2018

Affected Products

Product: Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.

All lots.

Product: Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

All lots.

Product: Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.

All lots.

Product: Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay

All lots.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79708

Status: Resolved

Manufacturer: Tosoh Bioscience Inc

Manufactured In: United States

Units Affected: 4 products (6049; 1485; 2864; 2258)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots.

Product: Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

All lots.

Product: Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.

All lots.