Siemens Healthcare Recalls HSV-2 Test Kits for False Positive Results
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.
Lower-risk 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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/63295-siemens-healthcare-recalls-hsv-2-test-kits-for-false-positive.
Source Summary by GovInfoNow · govinfonow.com/recall/63295-siemens-healthcare-recalls-hsv-2-test-kits-for-false-positive · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1274-2021
Cite this page
“Siemens Healthcare Recalls HSV-2 Test Kits for False Positive Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63295-siemens-healthcare-recalls-hsv-2-test-kits-for-false-positive. Based on FDA recall #Z-1274-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1274-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Product
Siemens Healthcare Diagnostics, Inc recalls Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot numbers B33255, B33269, or B33413 on the test kit.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
FDA distribution: “Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Illinois, Maryland, New Jersey, New York, Tennessee, Texas.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any safety risks from using these kits?
The recall is for potential false positive results, not a physical safety hazard. There is no risk of injury from using the kits.
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Where this comes from
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.
- Official source: FDA Recall #Z-1274-2021 (February 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1274-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.