Aptio Automation Storage and Retrieval Module — Class II medical device recall Z-2091-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-07-12, distributed nationwide. A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an inc
| Recall number | Z-2091-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2023-05-16 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, DE, ES, FR, GB, GR, IT, PT, SA, SE |
| Quantity | 83 units |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 00630414596754 |
| Model numbers | 10713762, 10715227 |
Product
Aptio Automation Storage and Retrieval Module (SRM)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2091-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.