Z-2091-2023Class II

Aptio Automation Storage and Retrieval Module (SRM)

Name: Z-2091-2023 Aptio Automation Storage and Retrieval Module (SRM)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-05-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-05-16 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Aptio Automation Storage and Retrieval Module (SRM) on 2023-05-16. FDA classified it as Class II and gives the reason as "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...". 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-2091-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-16
Posted: 2023-07-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Aptio Automation Storage and Retrieval Module (SRM)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: The firm sent a recall letter dated 05/16/2026 to consignees notifying them of the firmware issue presenting with this recall event. Consignees are asked to conduct visual checks of the device's gates at the buffer lane entry daily to ensure there are no obstructions that prevent the correct activation and movement of the divert, the divert looks intact, and the position of the divert is aligned to the profiles when it is diverting a tube without any missing or partial blocking of the carrier. If the visual check does not pass, contact your local technical support for assistance before using the impacted system. Until a service visit to upgrade the firmware of affected devices can be conducted, consignees are asked to maintain awareness of the provided recall notice and conduct daily recommended actions. Consignees are asked to complete and return the provided response form within 7 days of recall notification. Completed forms are to be emailed to [email protected] or faxed to (312)274-7795. Customers with any questions are asked to contact their local Siemens Healthineers Customer Care Center or technical support representative.
Quantity in commerce: 83 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, & United Kingdom.
Product codes and lots: Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05

Product code JJE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)