FDA-Device2021-03-24Class II
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Siemens Healthcare Diagnostics, Inc
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.
Sold states
Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Affected count
390 kits total (Domestic 366 kits, Foreign 24 kits)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2021Don't want to check this manually?
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