CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
Thyroglobulin Antibody (TgAB) Calibrator recalled by Tosoh Bioscience
Tosoh Bioscience is recalling Thyroglobulin Antibody (TgAB) Calibrator, distributed nationwide in the US. The recall was initiated on 23 Feb 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1187-2021
- FDA event ID
- 76372
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2012
- FDA classified
- 8 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Feb 2012 | Recall initiated by company | |
| 8 Mar 2021 | Classified by FDA | +3301 days |
| 17 Mar 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
Questions about this recall
Why was it recalled?
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Which lots are affected?
Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.
Where was it sold?
US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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