medical Class II Updated 2018-05-23

Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 Th

Recalled 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.


Hazard / Issue

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots.
View official government recall

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