Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only fo

Recalled May 23, 2018 · FDA recall Z-1811-2018 · Tosoh Bioscience

Hazard

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

Units

2864

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 Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.

Manufacturer(s)

Tosoh Bioscience Inc

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