Z-0193-2022Class II

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW)...

Name: Z-0193-2022 Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-10-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-10-06 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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 on 2021-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0193-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-06
Posted: 2021-11-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 code: CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
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.
Root cause tag: software
FDA root cause: Software design
Action: On October 6, 2021, the firm notified affected customers via an "Urgent Medical Device Correction" letter. Customers were informed of the product issue and provided instructions on actions to be taken by laboratories, which prevent the issue from happening. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. A new version of the Firmware for the Aptio Automation Interface Module to the ADVIA Centaur XP/XPT will correct the issue. Your service provider will contact you to schedule the firmware upgrade.
Quantity in commerce: 1142
Distribution: Worldwide distribution.
Product codes and lots: UDI 00630414596754

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0193-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-02

Product code CDT

K043546Class IDimension Rxl Max with Streamlab Analytical Workcell and Sample Transfer ModuleDade Behring, Inc. / cleared 2005-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)