Dimension Rxl Max with Streamlab Analytical Workcell and Sample Transfer Module

• • Ongoing Z-2091-2023 FDA Class II ·initiated 16 May 2023 ·via K043546, on the same 510(k)

  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.

• • Ongoing Z-0193-2022 FDA Class II ·initiated 6 Oct 2021

  The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

• • Terminated Z-1205-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009

  Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K043546 ↗

FDA Product Code

CDT

Device Class

Class I

Regulation

21 CFR Part 862.1705

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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