Tosoh Bioscience, Inc. recalls AIA-PACK TgAb CONTROL SET

Recall date

February 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2169-2017

FDA classification

Class III

Brand / firm

Tosoh Bioscience, Inc.

Sold / distributed

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

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

AIA-PACK TgAb CONTROL SET