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
Check against the official notice below — it lists the full affected range.
Meridian Bioscience Inc. is recalling Revogene nucleic acid testing instruments (Meridian catalog number 610210 and GenePOC branded versions) used in clinical laboratories for diagnostic testing. The photomultiplier tube in some instruments may not function properly, which can cause users to see more false-positive or indeterminate test results than normal. The recall affects 452 units worldwide, including 398 in the United States across most states and 54 units internationally in Australia, Chile, Italy, and Switzerland. All serial numbers of instruments with UDI 00840733102318 are included in this recall.
The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 452 units (398 US, 54 OUS) Lot/code info: UDI: 00840733102318 All units in the field, all serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.