Enzyme linked immunosorbent assay, for herpes simplex… recallZ-1274-2021 · Siemens Healthcare Diagnostics, Inc · initiated Feb 8, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-1274-2021
- Status
- Terminated
- Initiated by the company
- Feb 8, 2021
- Posted by the FDA
- Mar 18, 2021
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 390 kits total (Domestic 366 kits, Foreign 24 kits)
- Product code
- MYF
- FDA submissions
- K181334
- Distribution
- Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Product description
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Code information (models, lots, serial numbers)
***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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ADVIA Centaur Herpes-2 IgG 10720849Siemens Healthcare Diagnostics Inc. · Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page