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Terminated

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.

FDA Recall Z-1187-2021 · Posted None

Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeJZO
Date Initiated2012-02-23
Date Terminated2021-07-08
Product Quantity34 boxess/2 sets/6 bottles

Reason for Recall

Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.

Firm Action

On 7/24/2012 the firm sent recall notificaiton letters to their customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981522AIA-PACK TGAB ASSAYTosoh Medics, Inc. · 1998-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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