Meridian Bioscience Inc 2022-04-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0836-2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical… Recall
Issued April 6, 2022 · Meridian Bioscience Inc
In April 2022, Meridian Bioscience Inc recalled the Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
What you should do
- 1 Stop using Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Meridian Bioscience 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
- Meridian Bioscience Inc
- Category
- Health
- Recall date
- April 6, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME,
- Recall number
- FDA-Z-0836-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Meridian Bioscience Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.