Lower riskMedical device recall · FDA · Published September 13, 2024
DRG 17-OH Progesterone Kit Recall: Incorrect Control Ranges May Delay Results
DRG recalls 17-OH Progesterone ELISA kits with mismatched control ranges that could delay test results and pose a remote health risk. Affected kits have specific model and lot numbers.
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.
“DRG 17-OH Progesterone Kit Recall: Incorrect Control Ranges May Delay Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54024-drg-17-oh-progesterone-kit-recall-incorrect-control-ranges-may. Based on FDA recall #Z-0258-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0258-2025%22&limit=1).
The FDA announced on Sept. 13, 2024, that DRG International, Inc. is recalling its 17-OH Progesterone ELISA 96 well kit due to control acceptance range defects. This error may delay test results and pose a remote adverse health risk.
How to tell if you have it
Brand: DRG
Product: 17-OH Progesterone ELISA 96 well kit
Model/Catalog Number: EIA-1292
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
The hazard
The High and Low Control acceptance ranges in the Certificate of Analysis did not match the information on the control component labels. Due to this 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.
Context
GovInfoNow's records show DRG International, Inc. has five other recalls on record since Oct. 18, 2021. Other recent recalls include the T4 Total ELISA Kit (June 4, 2025), DRG Hybrid-XL Insulin (Oct. 7, 2024), and DRG Salivary Testosterone ELISA SLV-3013 (July 5, 2024). Other recent recalls of similar products include the Estrogen Progesterone Test (Nov. 3, 2025), Immunotech Estrone RIA Kit (Dec. 15, 2025), and Medline PPE Kit DYK1011945P (Jan. 7, 2026).
How to tell if you have this one
Check for model EIA-1292 with lot numbers 22K024 or 2:2K034. The kits are sold by DRG Instruments GmbH for medical testing.
Brand
DRG
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the model number (EIA-1292) and lot number (22K024 or 22K034) on the kit packaging.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, New Hampshire.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0258-2025 (September 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0258-2025 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.