Z-0193-2022 Class II Ongoing
FDA device recall Z-0193-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on October 6, 2021 and is designated Class II. Reason for recall: 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 cou… The recall status is ongoing. Affected quantity: 1142.
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- October 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1142
Product 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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI 00630414596754