Home / Recalls / Medical Devices
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In V
Recalled May 23, 2018 · FDA recall Z-1812-2018 · Tosoh Bioscience
Hazard
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. · FDA Class II
Units
2258
Sold at
USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Description
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
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
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →