Device product

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

Z-1274-2021

February 08, 2021

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 87381
Status: Terminated
Classification: Class II
Quantity: 390 kits total (Domestic 366 kits, Foreign 24 kits)
Official record key: device-enforcement:Z-1274-2021

Official wording

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.

Code information: ***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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.