—#185931

Product

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

FDA product code: MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K181334
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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

Timeline

Recall initiated: 2021-02-08
Posted by FDA: 2021-03-18
Terminated: 2025-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.