Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1274-2021 · Posted 2021-03-18

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeMYF
Date Initiated2021-02-08
Date Terminated2025-02-07
Product Quantity390 kits total (Domestic 366 kits, Foreign 24 kits)

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.

Firm Action

In February 2021, Siemens will issue an Urgent Medical Device Correction notice to customers via letter stating that Siemens Healthcare Diagnostics Inc. has confirmed that the ADVIA Centaur HSV2 assay does not meet the 60 day onboard stability or the 28 day calibration frequency (interval) as stated in the ADVIA Centaur XP/XPT Herpes-2 IgG (HSV2).

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A. · 2018-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑