medical Class II Updated 2021-03-24

Siemens Healthcare Diagnostics, Inc recalls Enzyme linked immunosorbent assay, for herpes simplex virus,

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CA, FL, IL, MD, NJ, NY, TN, TX

Lot/Code Info: ***Updated as of 3/25/2021*** Lot #: B33255, B33269, B33413. UDI #: (01)00630414016726(10)B33255(17)20210625, (01)00630414016726(10)B33269(17)20210629, (01)00630414016726(10)B33413(17)20210819. Updated as of 3/25/2021

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