ST AIA-PACK¿ PROG III — Class II medical device recall Z-0826-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-03-07, distributed in AK, AL, AR, AZ, CA, CO, DE, FL…. Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due t
| Recall number | Z-0826-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2018-02-13 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-10-29 |
| Distributed | 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, WI |
| Quantity | 3,322 |
| Reason classes | potency |
| Model numbers | 025240 |
Product
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0826-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.