Z-2168-2017 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- February 8, 2017
- Termination Date
- February 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 boxes
Product Description
AIA-PACK TPOAb CONTROL SET
Reason for Recall
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.
Distribution Pattern
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Code Information
TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017