17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnos...

FDA Device Recall #Z-0258-2025 — Class III — September 13, 2024

Recall Summary

Recall Number Z-0258-2025
Classification Class III — Low risk
Date Initiated September 13, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DRG International, Inc.
Location Springfield, NJ
Product Type Devices
Quantity 504 units

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

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.

Distribution Pattern

AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam

Lot / Code Information

Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034

Other Recalls from DRG International, Inc.

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Z-2622-2024 Class III Product Name: Salivary Testosterone ELISA Mode... Jul 5, 2024
Z-0896-2022 Class II C-Peptide ELISA : IVD measurement of C-Peptide ... Dec 21, 2021
Z-0310-2022 Class II Total Thyroxine (T4) ELISA; REF EIA-1781 Oct 18, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.