Device product
AIA-PACK TgAb CONTROL SET
Z-2169-2017
Product summary
- Event
- Event 76659
- Status
- Terminated
- Classification
- Class III
- Quantity
- 64 boxes
- Official record key
device-enforcement:Z-2169-2017
Official wording
Reason: 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.
Code information: TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
Distribution pattern: Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Derived failure modes
-
Unknown
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.