Enzyme linked immunosorbent assay — Class II medical device recall Z-1274-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2021-03-24, distributed in AL, CA, FL, GA, IL, MD, NJ, NY…. Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Ce
| Recall number | Z-1274-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2021-02-08 |
| Classified | 2021-03-18 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2025-02-07 |
| Distributed | AL, CA, FL, GA, IL, MD, NJ, NY, TN, TX |
| Countries outside the US | CL, ES, NP |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00630414016726 |
| Lot numbers | B33255, B33269, B33413 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1274-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.