FDAFDA · Food and drugs·Recall number Z-2168-2017
AIA-PACK TPOAb CONTROL SET
Published June 7, 2017 · Recall initiated: February 8, 2017
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 label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tosoh Bioscience, Inc.
- Distributor
- Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- Lot
- TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.