Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Tosoh Bioscience Inc is recalling 39 boxes of AIA-PACK BHCG Calibration Verification Test Sets (Part number: 020661). The affected lots are J803507, JX03508, JZ03509, A203510, and A403511. These in vitro diagnostic products are intended for the calibration of the ST AIA-PACK BHCG assay.
The recall was initiated because of decreased stability in the calibrator sets, which results in a decrease in the measured concentration of HCG by up to 20%. This defect may lead to inaccurate calibration of the diagnostic assay.
The affected products were distributed worldwide, including nationwide in the United States and in Bogota, Cayman Islands, Mexico, Peru, and San Salvador. Users should stop using the affected lots and contact Tosoh Bioscience Inc for further instructions.
The recalled product
- Product
- Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 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
- 39
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: J803507
- JX03508
- JZ03509
- A203510
- A403511
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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