Reported Mar 17, 2021 · Terminated
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the…
Tosoh Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
- Thyroglobulin Antibody (TgAB)
- Calibrator - Product Usageintended 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 IUPlease note that the Calibrator set is not part of the IU but required for the assay
- Lot codes and dates
Part Number 020391Lot # B834868Lot # BX34869Lot # C234871Lot # C434872 & Lot # C534873
- Amount recalled
- 34 boxess/2 sets/6 bottles
Where it was sold
Why it was recalled
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
This product could cause temporary or reversible health problems — stop using it.
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