Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

AIA-PACK TPOAb CONTROL SET Recalled by Tosoh Bioscience, Inc. Due to The label contains two different methodologies. Quality Control...

Date: February 8, 2017
Company: Tosoh Bioscience, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience, Inc. directly.

Affected Products

AIA-PACK TPOAb CONTROL SET

Quantity: 15 boxes

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: AK, FL, GA, MA, NY, OH, OK, TX

Affected (8 states)Not affected

About Tosoh Bioscience, Inc.

Tosoh Bioscience, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report