Lower riskMedical device recall · FDA · Published October 6, 2021
Siemens Centaur XP/XPT Interface Module Recall: Incorrect Test Results Risk
Siemens recalls Centaur XP/XPT interface modules with outdated firmware that may cause test results to be misassigned, affecting clinical decisions. Affected units include specific model versions sold with UDI 00630414596754.
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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr · Newark, DE 19702-2466
“Siemens Centaur XP/XPT Interface Module Recall: Incorrect Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61713-siemens-centaur-xp-xpt-interface-module-recall-incorrect-test-results. Based on FDA recall #Z-0193-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0193-2022%22&limit=1).
The FDA announced on Oct. 6, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling the Aptio Automation Interface Module to ADVIA Centaur XP/XPT due to firmware errors that may cause incorrect association of test results to sample IDs. This Class II recall affects 1,142 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: Aptio Automation Interface Module to ADVIA Centaur XP/XPT
Firmware: Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower
SMN: 10703038
UDI: 00630414596754
The hazard
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.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk (July 15, 2026) and Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for the model number CENa_3-1-0-1 and lower in the firmware. Affected units have a unique device identifier (UDI) starting with 00630414596754.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Firmware Version
Verify the firmware version on the interface module; affected units have CENa_3-1-0-1 and lower.
How this recall unfolded
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0193-2022 (October 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0193-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.