17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the… — Class III medical device recall Z-0258-2025
Ongoing recall by DRG International, Inc., reported 2024-11-06, distributed in AZ, CA, GA, NH. The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance
| Recall number | Z-0258-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2024-09-13 |
| Classified | 2024-10-29 |
| Reported by FDA | 2024-11-06 |
| Distributed | AZ, CA, GA, NH |
| Countries outside the US | AT, BE, DE, ES, GR, IN, IT, NL, PL, RO, RU, SG, VN |
| Quantity | 504 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04048474012927 |
| Lot numbers | 22K024, 22K034 |
| Model numbers | EIA-1292 |
Product
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
Reason for recall
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
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-0258-2025. 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.