Z-1187-2021Class II

Thyroglobulin Antibody (TgAB) Calibrator -

Name: Z-1187-2021 Thyroglobulin Antibody (TgAB) Calibrator -
Creator: Tosoh Bioscience Inc
Published: 2012-02-23
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2012-02-23 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin... on 2012-02-23. FDA classified it as Class II and gives the reason as "Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1187-2021
Classification: Class II
Status: Terminated
Initiated: 2012-02-23
Posted: 2021-03-08
Terminated: 2021-07-08
Recalling firm: Tosoh Bioscience Inc
Product: Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 7/24/2012 the firm sent recall notificaiton letters to their customers.
Quantity in commerce: 34 boxess/2 sets/6 bottles
Distribution: US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
Product codes and lots: Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1187-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-08

Product code JZO

K981522Class IIAia-Pack Tgab 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)