Z-1274-2021 Class II Terminated
FDA device recall Z-1274-2021 was initiated by Siemens Healthcare Diagnostics, Inc on February 8, 2021 and is designated Class II. 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) Failur… The recall status is terminated (terminated February 7, 2025). Affected quantity: 390 kits total (Domestic 366 kits, Foreign 24 kits).
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 8, 2021
- Termination Date
- February 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390 kits total (Domestic 366 kits, Foreign 24 kits)
Product Description
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
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 Pattern
Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Code Information
***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