The Recall Desk
HighFDA (Devices)·Z-2091-2023·Announced 2023-07-12

Aptio Storage and Retrieval Module firmware error may cause incorrect test results

Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with a firmware error that may cause incorrect patient test results. The source does not report any illnesses, injuries, or deaths. Per the rubric, a risk-of-harm product with theoretical hazard and no reported incidents scores 3 (High).

Plain-English summary

The FDA is recalling the Aptio Automation Storage and Retrieval Module (SRM) manufactured by Siemens Healthcare Diagnostics, Inc. A firmware error in the module may cause test results to be incorrectly associated with the wrong patient sample.

The error occurs only under very specific conditions: when the SRM module releases a sample tube at the exact moment another sample is not properly diverted into the module buffer, combined with a divert gate malfunction and a narrow timing window. When these conditions align, the firmware misidentifies which sample contains which test results and the system loses the ability to track one of the samples. This mis-association may result in incorrect patient results or delayed testing.

Eighty-three units worldwide are affected, including Model Nos. 10713762 and 10715227 with software versions prior to version 38. These systems are located in healthcare facilities across the United States (including California, Colorado, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia) and internationally in Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, and the United Kingdom.

The recalled product

Product
Aptio Automation Storage and Retrieval Module (SRM)
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Laboratory Automation
Hazard
  • test-result-misassociation
  • incorrect-patient-result
  • loss-of-sample-traceability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. 10713762 and 10715227
  • UDI-DI: 00630414596754
  • All units with software versions prior to 38.

Distribution

Distributed nationwide across the United States.

Related recalls

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