Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
- Recall Initiated
- February 8, 2021
- Posted
- March 18, 2021
- Terminated
- February 7, 2025
- Recall Number
- Z-1274-2021
- Quantity
- 390 kits total (Domestic 366 kits, Foreign 24 kits)
- Firm Location
- East Walpole, MA
Reason for Recall
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.
Distribution
Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Lot / Code Info
***Updated as of 3/25/2021*** Lot #: B33255, B33269, B33413. UDI #: (01)00630414016726(10)B33255(17)20210625, (01)00630414016726(10)B33269(17)20210629, (01)00630414016726(10)B33413(17)20210819. Updated as of 3/25/2021
Root Cause
Under Investigation by firm
Action Taken
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).