—#200970

Product

Aptio Automation Storage and Retrieval Module (SRM)

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K043546
Affected lot / code info: Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 escctsfcaecfax.team@siemens-healthineers.com 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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-05-16
Posted by FDA: 2023-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200970. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.