Tosoh recalls specific lots of AIA-Pack BHCG Calibrator Sets for potential HCG concentration decrease up to 20% in in vitro diagnostics.
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
Tosoh is recalling five specific lots of AIA-Pack BHCG Calibrator Sets due to decreased stability, which could lead to HCG concentration measurements being up to 20% lower than expected. This affects in vitro diagnostic testing accuracy.
The calibrator sets in the recalled lots have decreased stability, causing HCG concentration measurements to be up to 20% lower than intended. This could lead to inaccurate pregnancy test results if used in the ST AIA-PACK BHCG assay.
Users of the AIA-Pack BHCG Calibrator Sets for in vitro diagnostics are affected. Those testing pregnancy with the ST AIA-PACK BHCG assay are most at risk.
Check the lot numbers on the calibrator set: J833531, JX33532, JZ33533, A233534, or A4333535. The product is sold as an in vitro diagnostic for pregnancy testing.
Verify the lot number on the calibrator set to see if it matches the recalled lots: J833531, JX33532, JZ33533, A233534, or A4333535.
The recalled lots have decreased stability, which can cause HCG concentration measurements to be up to 20% lower than intended, potentially affecting test accuracy.
Check the lot number on the calibrator set. If it matches the recalled lots, stop using it and contact Tosoh Bioscience for guidance.
The recall record does not mention a remedy or fix for the recalled product.
We’ve drafted a message you can send Tosoh Biosc: AIA-Pack BHCG Calibrator to request your refund or repair — edit it as you like.
Subject: Recall Z-2967-2020 — Tosoh Biosc: AIA-Pack BHCG Calibrator Tosoh Biosc: AIA-Pack BHCG Calibrator Hello, I own a Tosoh Biosc: AIA-Pack BHCG Calibrator that is covered by recall Z-2967-2020 from Tosoh Biosc: AIA-Pack BHCG Calibrator. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
