Class 2 Device Recall Aptio Automation

• Date Initiated by Firm: May 16, 2023
• Date Posted: July 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2091-2023
• Recall Event ID: 92461
• 510(K)Number: K043546
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Aptio Automation Storage and Retrieval Module (SRM)
• Code Information: Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38.
• FEI Number: 2517506
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr; Newark DE 19702-2466
• For Additional Information Contact: Jeff Semone; 800-441-9250
• Manufacturer 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.
• FDA Determined 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 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE