Z-2169-2017 Class III Terminated
FDA device recall Z-2169-2017 was initiated by Tosoh Bioscience, Inc. on February 8, 2017 and is designated Class III. 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 inst… The recall status is terminated (terminated February 8, 2019). Affected quantity: 64 boxes.
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
- 64 boxes
Product Description
AIA-PACK TgAb 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
TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.