Siemens Healthcare Diagnostics, Inc Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.

Recommended Action

Per FDA guidance

In February 2021, Siemens will issue an Urgent Medical Device Correction notice to customers via letter stating that Siemens Healthcare Diagnostics Inc. has confirmed that the ADVIA Centaur HSV2 assay does not meet the 60 day onboard stability or the 28 day calibration frequency (interval) as stated in the ADVIA Centaur XP/XPT Herpes-2 IgG (HSV2).

Distribution

As reported by FDA

AL, CA, FL, GA, IL, MD, NJ, NY, TN, TX