Siemens Healthcare Diagnostics, Inc. Recall 88865
Description: Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Siemens Healthcare Diagnostics, Inc. Recall 88865 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0193-2022 |
| Event ID | 88865 |
| Event Description | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 1142 |
| Recall Reason | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions. |
| Device Classification | 20211110 |
| Device Code Info | UDI 00630414596754 |
| Center Classification Date | 20211102 |
| Recall Initiation Date | 20211006 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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