Open, Classified

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

FDA Recall Z-0836-2022 · Posted None

Recall StatusOpen, Classified

Product CodeOOI

Date Initiated2022-02-15

Product Quantity452 units (398 US, 54 OUS)

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.

Firm Action

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.

Root Cause

Component design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170558revogeneGenepoc, Inc. · 2017-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.