Siemens Healthcare recalls Aptio Automation Storage and Retrieval Modules with older software versions due to potential incorrect patient test results from misassociated sample tubes.
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.
Siemens Healthcare is recalling Aptio Automation Storage and Retrieval Modules (SRM) with software versions older than 38. This could cause test results to be incorrectly linked to patient samples, potentially leading to wrong patient diagnoses.
The system may misidentify a sample tube as another tube due to a firmware error, causing the wrong test results to be linked to a patient. This happens only when specific timing conditions are met during sample handling.
Healthcare facilities using Siemens Aptio SRM models 10713762 and 10715227 with software versions before 38 are affected. Lab technicians and patients receiving tests from these systems are at risk of incorrect results.
Check for Siemens Aptio SRM models 10713762 or 10715227 with software versions older than 38. The units have a unique identifier (UDI-DI: 00630414596754).
Verify the software version on your Aptio SRM; if it's older than version 38, it's affected.
The recall involves a firmware error that could cause test results to be incorrectly linked to patient samples, potentially leading to wrong diagnoses.
Check for Siemens Aptio SRM models 10713762 or 10715227 with software versions older than 38. The units have a unique identifier (UDI-DI: 00630414596754).
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2091-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2091-2023 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
