Recall Z-2168-2017
Tosoh Bioscience, Inc. · initiated February 8, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
AIA-PACK TPOAb CONTROL SET
Codes / lots: TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
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.
FDA-determined cause: Labeling mix-ups
Action taken
On 3/3/2017 the firm sent recall notificaion letters to their customers.
Details
- Recall number
- Z-2168-2017
- Initiated
- February 8, 2017
- Posted by FDA
- May 15, 2017
- Terminated
- February 8, 2019
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Quantity
- 15 boxes
- Distribution
- Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- Recalling firm
- Tosoh Bioscience, Inc., South San Francisco, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2169-2017 Class III | AIA-PACK TgAb CONTROL SETThe label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL)… | 02/08/2017Terminated |