Z-0836-2022 Class II Ongoing
FDA device recall Z-0836-2022 was initiated by Meridian Bioscience Inc on February 15, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 452 units (398 US, 54 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2022
- Initiation Date
- February 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 452 units (398 US, 54 OUS)
Product Description
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
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UDI: 00840733102318 All units in the field, all serial numbers.