Tosoh Bioscience, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2168-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AIA-PACK TPOAb CONTROL SET

Product Classification:

Class III

Date Initiated: February 8, 2017

Date Posted: June 7, 2017

Recall Number: Z-2168-2017

Event ID: 76659

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.

Status: Terminated

Product Quantity: 15 boxes

Code Information:

TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017

Distribution Pattern:

Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.

Voluntary or Mandated:

Voluntary: Firm initiated