Siemens Healthcare Diagnostics, Inc Recall 87381
Description: Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Siemens Healthcare Diagnostics, Inc Recall 87381 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1274-2021 |
| Event ID | 87381 |
| Event Description | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 |
| Product Type | Devices |
| Distribution | Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain. |
| Quantity | 390 kits total (Domestic 366 kits, Foreign 24 kits) |
| Recall 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. |
| Device Classification | 20210324 |
| Device 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 |
| Center Classification Date | 20210318 |
| Recall Initiation Date | 20210208 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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