Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Enzyme linked immunosorbent assay Recalled by Siemens Healthcare Diagnostics, Inc Due to Potential false positive HSV results. Siemens Healthcare Diagnostics,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc directly.
Affected Products
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Quantity: 390 kits total (Domestic 366 kits, Foreign 24 kits)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 9 states: AL, CA, FL, IL, MD, NJ, NY, TN, TX
About Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report