Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use O

Recalled May 23, 2018 · FDA recall Z-1810-2018 · Tosoh Bioscience

Hazard

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. · FDA Class II

Units

1485

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 Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

Manufacturer(s)

Tosoh Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →