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Siemens Healthcare Diagnostics, Inc recalls Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Recalled March 24, 2021 · FDA recall Z-1274-2021 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
390 kits total (Domestic 366 kits, Foreign 24 kits)
Sold at
Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Description
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.
Product
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →