17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay… recallZ-0258-2025 · DRG International, Inc. · initiated Sep 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DRG International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take: Please check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay. Immediately reply to email: [email protected] to confirm this notice and your compliance.
Recall details
- Recall number
- Z-0258-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2024
- Posted by the FDA
- Oct 29, 2024
- Recalling firm
- DRG International, Inc.
- Quantity
- 504 units
- Product code
- JLX
- Distribution
- AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Product description
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
Code information (models, lots, serial numbers)
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 17 OH-Progesterone ELISA EIA-1292DRG Instruments Gesellschaft mit beschränkter Haftung · Radioimmunoassay, 17-Hydroxyprogesterone1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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