Z-1811-2018 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
- 2864
Product Description
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.
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.