medical Class II Updated 2018-05-23

Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretrea

Recalled 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

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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