FDAFDA · Food and drugs·Recall number Z-0836-2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
Published April 6, 2022 · Recall initiated: February 15, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Meridian Bioscience Inc
- Distributor
- 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, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.
- Lot
- UDI: 00840733102318 All units in the field, all serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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