Tosoh Bioscience recalls specific lots of BHCG pregnancy test sets due to potential 20% lower HCG concentration readings. Affected units may give inaccurate pregnancy results. Contact for replacement.
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 Bioscience is recalling five specific lots of BHCG pregnancy test calibration sets because they may show up to 20% lower HCG concentrations than expected. This could lead to false negative pregnancy results if used normally.
The recalled calibration sets may measure HCG levels up to 20% lower than they should. This could cause pregnancy tests to show negative results when a pregnancy actually exists, leading to missed pregnancies.
Pregnancy test users who purchased the specific lots listed (J803507, JX03508, JZ03509, A203510, A403511) from the manufacturer. Women who rely on these tests for pregnancy confirmation are most at risk of false negatives.
Check the lot number on the packaging: J803507, JX03508, JZ03509, A203510, or A403511. These are the only affected lots of the AIA-PACK BHCG Calibration Verification Test Sets.
Look for the lot numbers J803507, JX03508, JZ03509, A203510, or A403511 on the test set packaging.
The recalled lots may show up to 20% lower HCG concentrations than expected, which could cause false negative pregnancy test results.
Check the lot number on the packaging: J803507, JX03508, JZ03509, A203510, or A403511.
The recall does not specify a replacement or remedy, so contact Tosoh Bioscience directly for assistance.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2968-2020 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2968-2020 from Tosoh Bioscience. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
