Z-2168-2017Class III

AIA-PACK TPOAb CONTROL SET

Name: Z-2168-2017 AIA-PACK TPOAb CONTROL SET
Creator: Tosoh Bioscience, Inc.
Published: 2017-02-08
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2017-02-08 / Terminated / root cause: labeling and UDI

FDA source

Tosoh Bioscience, Inc. began a recall of AIA-PACK TPOAb CONTROL SET on 2017-02-08. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2168-2017
Classification: Class III
Status: Terminated
Initiated: 2017-02-08
Posted: 2017-05-15
Terminated: 2019-02-08
Recalling firm: Tosoh Bioscience Inc
Product: AIA-PACK TPOAb CONTROL SET
Product code: JZO System, Test, Thyroid Autoantibody
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 3/3/2017 the firm sent recall notificaion letters to their customers.
Quantity in commerce: 15 boxes
Distribution: Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Product codes and lots: TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2168-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2168-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-26
Z-2169-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-26

Product code JZO

K981521Class IIAia-Pack Tpoab AssayTosoh Medics, Inc. / cleared 1998-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)