Device Recall Tosoh ST AIAPACK HbA1c Calibrator

All lots.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

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.