Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. recalled ADVIA Centaur4P Herpes-2 IgG (HSV2) test kits used on ADVIA Centaur XP System and ADVIA Centaur XPT System equipment due to potential false positive HSV results caused by onboard stability and calibration frequency failures. A total of 390 kits were distributed domestically across nine states (Alabama, California, Florida, Illinois, Maryland, New Jersey, New York, Tennessee, and Texas) and internationally to Nepal, Chile, Georgia, and Spain. The affected kits are identified by lot numbers B33255, B33269, and B33413.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 390 kits total (Domestic 366 kits, Foreign 24 kits) 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.