Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vit…

Recall date

March 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1812-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

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.

Why it was recalled

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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