BEUDAMED
    FDA Recall Terminated

    Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

    Recall: Z-1797-2020 · Initiated February 27, 2020

    Recall

    Recall Number
    Z-1797-2020
    Event Number
    85268
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 27, 2020
    Terminated
    October 25, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

    Reason

    Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

    Action

    An Urgent Medical Device Correction notification letter dated 2/27/20 was sent to customers. The purpose of this communication is to inform you of the issues listed in Table 2 below, that can occur on the Atellica CH 930 Analyzer, installed with Atellica Solution software (SW) versions v1.21.0 SP1 or lower and provide instructions on actions your laboratory must take. These issues will be corrected in SW v1.22.0 and v1.21.11, which will be available soon. Actions to be Taken by the Customer The following actions must be taken until your system has been updated to software version v1.22.0 (or V1.21.11 for Atellica Solution with decapper modules) or higher which resolves the issues listed above. 1. When making modifications to an assays Test Definition settings on the Setup>Test Definition>CH Test Definition screen, always follow the instructions outlined in the Atellica Solution online help 1.20 instructions Editing Assay Identification Parameters in CH Test Definition. Each Test Definition must be saved using the Save button on the CH Test Definition screen before starting modifications on another assays Test Definition. After changing any setting on the Definition, Calculation, or Calibration tabs of the CH Test Definition screen, select Save and then OK. Verify that QC results are not affected, and that results, units, and flags are reported correctly for any Test Definition that has been updated before running patient samples. 2. Ensure all reagent packs have a valid calibration (all wells) before running samples. This information is available on the screen Calibration > Calibration Overview. Refer to the Atellica Solution online help 1.20 instructions, Viewing Assay Reagent Calibration Order Status. When available, software v1.22.0 and/or v1.21.11 will be delivered as follows: For systems running software v1.19.0 or higher, that are connected to the Smart Remote Service (SRS), the software will be delivered electronically

    Distribution

    US Nationwide. Global distribution.

    Quantity

    1807