Skip to content
Recall Observatory FDA recall evidence

Device product

AIA-PACK TPOAb CONTROL SET

Z-2168-2017

February 08, 2017

Class III

Product summary

Firm
Tosoh Bioscience, Inc.
Event
Event 76659
Status
Terminated
Classification
Class III
Quantity
15 boxes
Official record key
device-enforcement:Z-2168-2017

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.