Recall Z-1274-2021 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Siemens Healthcare Diagnostics, Inc
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
| Date | Mar 18, 2021 (initiated Feb 8, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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). |
| Quantity | 390 kits total (Domestic 366 kits, Foreign 24 kits) |
| Distribution | Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181334 | ADVIA Centaur Herpes-2 IgG Biokit, S.A., Aug 23, 2018 |