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
Reported: November 10, 2021 Initiated: October 6, 2021 #Z-0193-2022
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1142
- Distribution
- Worldwide distribution.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1142.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0193-2022.
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