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
- Company
- Meridian Bioscience Inc
- Recall Initiated
- February 15, 2022
- Recall Number
- Z-0836-2022
- Quantity
- 452 units (398 US, 54 OUS)
- Firm Location
- Cincinnati, OH
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
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 / Code Info
UDI: 00840733102318 All units in the field, all serial numbers.
Root Cause
Component design/selection
Action Taken
A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results. If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue.