Z-1809-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- March 5, 2018
- Termination Date
- June 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6049
Product Description
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
Reason for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Distribution Pattern
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.
Code Information
All lots.