Used for ISCUSflex software Rev L Ver 2.1.0.391 or later only.

– Identify the LOT number on the Control sample bottle label.
– Click on the LOT number below.
– Extract (Unzip) the file
– Save the file nominalcontrols.ini on a USB memory for transfer to ISCUSflex using the service code:

‘NOMINAL CL LOAD’

Used for ISCUSflex software Rev L Ver 2.1.0.449 and later.

You may also use a scanner and scan the nominal control levels and the CLIA levels from the preferred specification sheet in the table.
Use the service code USE BARCODE SCANNER YES to activate bar code scanning.
Use the service code NOMINAL CL SCAN to scan the nominal control levels.

N.B. LOT numbers refer to the LOT number on the printed insert and the LOT number printed on the bottle label. The outer package has a label with a different LOT number.

Available LOT numbers

 

 

 

LOT number Expiry date Int. Spec. sheet US Spec. sheet
     T26110 2020-01-12
     T26191 2020-03-25  T26191 EU  T26191 US
     T26364 2020-07-13  T26364 EU  T26364 US
     T26367 2020-07-15  T26367 EU  T26367 US
     T26377 2020-08-01  T26377 EU  T26377 US
     T26842 2021-11-09 T26842 EU T26842 US
     T26977 2022-01-28 T26977 EU Corrected 2021-03-15 T26977 US Corrected 2021-03-15
     T27075 2022-05-24 T27075 EU Corrected 2021-03-15 T27075 US Corrected 2021-03-15
     T27280 2022-12-19 T27280 EU Corrected 2021-03-15 T27280 US Corrected  2021-03-15
     T27524 2023-08-28 T27524 EU T27524 US
     T27718 2023-12-13 T27718 EU T27718 US
     T27803 2024-02-28 T27803 EU T27803 US
     T27811 2024-07-16 T27811 EU T27811 US
     T28239 2025-08-04 T28239 EU T28239 US
     T28479 2026-07-20 T28479 EU T28479 US

For LOT T26110 and later (regarding Pyruvate reagent LOT T25967 and later) please also read here.

Pyruvate reagent LOT T25967 Restrictions

Pyruvate reagent LOT T25967 is the first lot for the restricted linearity interval 2 – 300 µmol/L. LOT T25967 is tested and approved for this interval, later LOTs will also be tested and approved for this interval until further notice.

Steps to ensure proper handling

  • ISCUSflex software update
    The ISCUSflex software has to be updated for this new linearity interval in order to present appropriate linearity level warnings, e.g. when running calibration verification samples.
    For qualified service Technicians only: A software update for ISCUSflex (Ver. 2.1.0.478) is available here.
  • Auto Controls
    In order to get proper Auto control results, Auto controls with LOT number T26110 or later must be used.
    N.B. It is imperative to update the auto control nominal values (and CLIA limits) in order to get proper results preferably using the scan codes.

Restricted Pyruvate linearity interval (10 - 300 µmol/L)

Starting from LOT T27254 the Low Pyruvate concentration has been raised to meet the new linearity interval. For optimal performance the ISCUSflex software shall be upgraded to version 2.1.0.485.

  • For qualified service Technicians only: A software update for ISCUSflex (Ver. 2.1.0.485) is available here.

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