Luminex Corporation 2022-07-13 Health serious FDA
Health · FDA · Recall #FDA-Z-1335-2022
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 Recall
Issued July 13, 2022 · Luminex Corporation
In July 2022, Luminex Corporation recalled the VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
What you should do
- 1 Stop using VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Luminex Corporation 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
- Luminex Corporation
- Category
- Health
- Recall date
- July 13, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- Recall number
- FDA-Z-1335-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Luminex Corporation has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.