Tosoh ST AIA-PACK PROG III Assay Recall: False Progesterone Results
Tosoh Bioscience recalls ST AIA-PACK PROG III assay (part 025240) due to false high progesterone readings from DHEA-S cross-reactivity. Affected units may give inaccurate test results.
Lower-risk recall
Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
Contact the company
What happened, in plain English
Tosoh Bioscience is recalling its ST AIA-PACK PROG III assay (part number 025240) because it can produce false high progesterone results when used with certain DHEA supplements. This could lead to incorrect medical decisions if the test is used for pregnancy or hormone monitoring. Read more at govinfonow.com/recall/71969-tosoh-st-aia-pack-prog-iii-assay-recall-false-progesterone.
Source Summary by GovInfoNow · govinfonow.com/recall/71969-tosoh-st-aia-pack-prog-iii-assay-recall-false-progesterone · Updated August 28, 2026 · FDA enforcement record: FDA #Z-0826-2018
Cite this page
“Tosoh ST AIA-PACK PROG III Assay Recall: False Progesterone Results.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71969-tosoh-st-aia-pack-prog-iii-assay-recall-false-progesterone. Based on FDA recall #Z-0826-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2018%22&limit=1).
Why it’s dangerous
The assay cross-reacts with DHEA-S, a metabolite found in DHEA supplements. This causes the test to show higher progesterone levels than actually present, potentially leading to incorrect medical conclusions.
Who’s affected
Users of this progesterone test kit, particularly those monitoring hormone levels or pregnancy, may get inaccurate results if they use the kit with DHEA supplements. People taking DHEA supplements are at higher risk of false readings.
How to tell if you have this one
Check for the part number 025240 on the ST AIA-PACK PROG III assay kit. All lots of this specific product are affected.
- Brand
Tosoh Biosc: Inc- 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
Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0825-2018 | ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239; All lots | 5579 |
| Z-0826-2018 | ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240; All lots | 3322 |
What to do — step by step
Check Kit Details
Look for the part number 025240 on the ST AIA-PACK PROG III assay kit.
Where it went and when
Where it was distributed
Distributed in 39 states.
FDA distribution: “Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.7 years 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.
Questions people ask
Do I need to stop using this kit?
No action is required beyond checking if you have the affected kit. The recall does not require immediate discontinuation.
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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-0826-2018 (February 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0826-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 28, 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.