FDA Enforcement
Class II
Terminated
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Recall: Z-1274-2021
·
Reported March 24, 2021
Enforcement
- Recall Number
- Z-1274-2021
- Event ID
- 87381
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 24, 2021
- Initiation Date
- February 8, 2021
- Classification Date
- March 18, 2021
- Termination Date
- February 7, 2025
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
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.
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
Distribution
Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Quantity
390 kits total (Domestic 366 kits, Foreign 24 kits)