Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Freque…

Recall #: Z-1274-2021
Affected scope: 390 kits total (Domestic 366 kits, Foreign 24 kits)
Initiated: February 8, 2021

Compiled from official public sources by the publisher. · Updated September 2026

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Siemens Healthcare Diagnostics, Inc recalled Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 - a moderate-severity action.

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 was recalled by Siemens Healthcare Diagnostics, Inc in March 24, 2021. Reason: Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA …. Check the official notice for the remedy. Verify recall #Z-1274-2021 with the FDA Devices before acting.

The recall

Siemens Healthcare Diagnostics, Inc issued this moderate-severity FDA Devices recall-Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA ….

Moderate
severity level: Class II
classification: March 24, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1274-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

Reason for 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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1274-2021
Date reported	March 24, 2021
Date initiated	February 8, 2021
Recalling firm	Siemens Healthcare Diagnostics, Inc
Firm location	East Walpole, MA
Affected scope	390 kits total (Domestic 366 kits, Foreign 24 kits)
Distribution	Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1274-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 390 kits total (Domestic 366 kits, Foreign 24 kits).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1274-2021.

Where was the recalled product distributed? ▼

Distribution: Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported March 24, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026