Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2091-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Aptio Automation Storage and Retrieval Module (SRM)

Product Classification:

Class II

Date Initiated: May 16, 2023

Date Posted: July 12, 2023

Recall Number: Z-2091-2023

Event ID: 92461

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.

Status: Ongoing

Product Quantity: 83 units

Code Information:

Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38.

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.

Voluntary or Mandated:

Voluntary: Firm initiated