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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-1809-2018 - 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) i... 2 05/14/2018 Tosoh Bioscience Inc
Z-1812-2018 - 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 ... 2 05/14/2018 Tosoh Bioscience Inc
Z-1811-2018 - 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. 2 05/14/2018 Tosoh Bioscience Inc
Z-1810-2018 - 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. 2 05/14/2018 Tosoh Bioscience Inc
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