Tosoh Bioscience AIA-PACK BHCG Test Set Recall: Decreased HCG Accuracy Risk
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.
Lower-risk recall
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%.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/64506-tosoh-bioscience-aia-pack-bhcg-test-set-recall-decreased-hcg.
Source Summary by GovInfoNow · govinfonow.com/recall/64506-tosoh-bioscience-aia-pack-bhcg-test-set-recall-decreased-hcg · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2968-2020
Cite this page
“Tosoh Bioscience AIA-PACK BHCG Test Set Recall: Decreased HCG Accuracy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64506-tosoh-bioscience-aia-pack-bhcg-test-set-recall-decreased-hcg. Based on FDA recall #Z-2968-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2968-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Tosoh Bioscience- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2967-2020 | 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; Lot Numbers: J833531, JX33532, JZ33533, A233534, A433535 | 289 boxes |
| Z-2968-2020 | 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; Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511 | 39 boxes |
What to do — step by step
Check Lot Number
Look for the lot numbers J803507, JX03508, JZ03509, A203510, or A403511 on the test set packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2968-2020 (August 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2968-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.