# FDA recall Z-1274-2021

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2021-02-08.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1274-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-08
- **Report date:** 2021-03-24
- **Termination date:** 2025-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2021

## Citation

> AI Analytics. FDA recall Z-1274-2021. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/Z-1274-2021. Source: US FDA. Licensed CC0.

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