FDA Device recall Z-2091-2023
Aptio Automation Storage and Retrieval Module (SRM)
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of Aptio Automation Storage and Retrieval Module (SRM) by Siemens Healthcare Diagnostics, citing 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 dela….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-16 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Aptio Automation Storage and Retrieval Module (SRM)
Reason
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.
Identifiers
| code_info | Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2023%22
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