Recall Z-2091-2023 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Storage and Retrieval Module (SRM)
| Date | Jul 5, 2023 (initiated May 16, 2023) |
| Status | Open, Classified |
| 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 t |
| 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE Dade Behring, Inc., Jan 18, 2005 |