FDA recall Z-1810-2018

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.

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-05-23

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2018