Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418
Recalled 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.
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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