AIA-PACK TPOAb CONTROL SET
This recall has been terminated (originally issued May 15, 2017).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- February 8, 2017
- Posted
- May 15, 2017
- Terminated
- February 8, 2019
- Recall Number
- Z-2168-2017
- Quantity
- 15 boxes
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
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
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Lot / Code Info
TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
Root Cause
Labeling mix-ups
Action Taken
On 3/3/2017 the firm sent recall notificaion letters to their customers.
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