Siemens Healthcare recalls specific HSV-2 test kits due to potential false positive results. Affected units may need recalibration to ensure accurate herpes virus testing.
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.
Siemens Healthcare is recalling certain herpes simplex virus type 2 (HSV-2) test kits because they may produce false positive results. This could lead to incorrect diagnoses and unnecessary treatment decisions.
The test kits may give false positive results for herpes simplex virus type 2 (HSV-2) due to calibration issues. This could lead to incorrect diagnoses and unnecessary treatment decisions.
People who use the specific HSV-2 test kits with lot numbers B33255, B33269, or B33413 are affected. Those who rely on these tests for herpes virus diagnosis are most at risk of incorrect results.
Check the lot number on the test kit: B33255, B33269, or B33413. The kits were sold with specific UDI numbers that include these lot codes.
Look for lot numbers B33255, B33269, or B33413 on the test kit.
The test kits may produce false positive results for herpes simplex virus type 2 (HSV-2) due to calibration issues.
Check the lot number on the test kit. If it matches B33255, B33269, or B33413, contact Siemens Healthcare for further instructions.
The recall is for potential false positive results, not a physical safety hazard. There is no risk of injury from using the kits.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1274-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1274-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
