Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
FDA device recall Z-1274-2021 · posted 2021-03-18 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- 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.
- Action taken
- 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).
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MYF
- Quantity affected
- 390 kits total (Domestic 366 kits, Foreign 24 kits)
- Distribution
- Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
- Date initiated
- 2021-02-08
- Date posted
- 2021-03-18
- Date terminated
- 2025-02-07
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |