FDA recall Z-1274-2021

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

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

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