FDAFDA · Food and drugs·Recall number Z-1811-2018
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.
Published May 23, 2018 · Recall initiated: March 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tosoh Bioscience Inc
- Distributor
- 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.
- Lot
- All lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.