Tosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures
Tosoh Bioscience Inc is recalling specific lots of Thyroglobulin Antibody Calibrators because some combinations with AIA PACKS resulted in unacceptable calibration values.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect leading to unacceptable calibration, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 34 boxes (2 sets of 6 bottles) of Thyroglobulin Antibody (TgAB) Calibrators. The affected lots are B834868, BX34869, C234871, C434872, and C534873, identified by Part Number 020391. These products were distributed nationwide in California, Florida, Georgia, New York, Ohio, and Oregon.
The recall was initiated because some combinations of the Calibrator lots and AIA PACKS resulted in Calibrator #6 not providing a value, making the calibration unacceptable. This device is intended for in vitro diagnostic use only for the quantitative measurement of anti-thyroglobulin antibodies in human serum on specific TOSOH AIA System analyzers.
Healthcare facilities and laboratories that possess these specific lots should stop using them and contact Tosoh Bioscience Inc for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- 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 dia
- Manufacturer
- Tosoh Bioscience Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Part Number 020391
- Lot # B834868
- Lot # BX34869
- Lot # C234871
- Lot # C434872 & Lot # C534873.
Distribution
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