Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues
Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.
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 the hazard involves a potential for inaccurate diagnostic results (up to 20% deviation) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/quality issues.
Plain-English summary
Tosoh Bioscience Inc is recalling five lots of AIA-PACK HCG Calibrator Sets (Part number 020361). The recall involves 289 boxes distributed worldwide, including the United States (nationwide), Bogota, Cayman Islands, Mexico, Peru, and San Salvador. The affected lot numbers are J833531, JX33532, JZ33533, A233534, and A433535.
The recall was initiated due to decreased stability in the calibrator sets. This stability issue results in a decrease in the measured concentration of Human Chorionic Gonadotropin (HCG) by up to 20%. The AIA-PACK BHCG Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK BHCG assay.
Healthcare facilities and laboratories that have purchased these specific lots should stop using the affected calibrator sets and contact Tosoh Bioscience Inc for further instructions. Consumers are not directly affected as this product is for professional in vitro diagnostic use.
The recalled product
- Product
- Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 289
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)
- Lot Numbers: J833531
- JX33532
- JZ33533
- A233534
- A433535
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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