DRG International, Inc. 2024-11-06 Health moderate FDA
Health · FDA · Recall #FDA-Z-0258-2025
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro… Recall
Issued November 6, 2024 · DRG International, Inc.
In November 2024, DRG International, Inc. recalled the 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact DRG International, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- DRG International, Inc.
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietn
- Recall number
- FDA-Z-0258-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- DRG International, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.