FDA Medical devices recall ·
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the… recall
- Recall number
- Z-0258-2025
- Date
- (initiated September 13, 2024)
- Company / brand
- DRG International, Inc.
841 Mountain Ave, Springfield, NJ, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 504 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Distribution
AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
States: Arizona California Georgia New Hampshire
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0258-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.