Recall Z-1274-2021— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1274-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-08

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2021-02-08, terminated 2025-02-07. It names one FDA 510(k) clearance: K181334. Product: Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-02-08
Terminated: 2025-02-07
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K181334 — ADVIA Centaur Herpes-2 IgGBiokit, S.A.·cleared 2018-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.