DRG International, Inc. 2024-08-21 Health moderate FDA
Health · FDA · Recall #FDA-Z-2622-2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product… Recall
Issued August 21, 2024 · DRG International, Inc.
In August 2024, DRG International, Inc. recalled the Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
What you should do
- 1 Stop using Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product… 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
- August 21, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Recall number
- FDA-Z-2622-2024
- 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.