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RCRP Customer Notification

Siemens Healthineers has issued a notification regarding a 'No Calculation' flag for the Atellica CH Revised C-Reactive Protein assay when CRP concentrations are below 0.05 mg/dL. This issue affects the reporting of results as 'Error' instead of a numerical value for certain samples, while results within the measuring interval remain unaffected. Customers are advised to implement specific actions to report these results correctly until a software resolution is available in the upcoming Atellica Solution Software update.

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129 views1 page

RCRP Customer Notification

Siemens Healthineers has issued a notification regarding a 'No Calculation' flag for the Atellica CH Revised C-Reactive Protein assay when CRP concentrations are below 0.05 mg/dL. This issue affects the reporting of results as 'Error' instead of a numerical value for certain samples, while results within the measuring interval remain unaffected. Customers are advised to implement specific actions to report these results correctly until a software resolution is available in the upcoming Atellica Solution Software update.

Uploaded by

sergio.fernandez.paneque
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Customer Notification

[Link]

Atellica CH Analyzer

Title Atellica CH Revised C-Reactive Protein (RCRP) “No Calculation” Flag


Date Issued SEP-2024
Issue Description Siemens Healthineers has confirmed the occurrence of “No Calculation” flags when using the
Atellica CH RCRP assay on the Atellica® CH Analyzer. This flag is only triggered for some
samples when the CRP concentration is less than the low end of the measuring interval of 0.05
mg/dL (0.5 mg/L). When this flag is triggered, the concentration/index is reported as “Error.”
Results within or above the measuring interval of 0.05 – 25.00 mg/dL (0.5 – 250.0 mg/L) are
not impacted. For the RCRP assay, no other conditions will trigger this flag.
This issue does not affect Atellica CH RCRP results on the Atellica® CI Analyzer.

Products Siemens Material Number/Unique Device


Assay Test Code Lot Number
Identification
Atellica CH Revised
C‑Reactive Protein RCRP 11537223/00630414610887 All lots
(RCRP)

Impact to Results For some results below the measuring interval, “Error” is posted instead of the numerical
result and should be reported as <0.05 mg/dL (<0.5 mg/L).
Customer Actions • For the product listed in the table above, please perform the following steps:
1. For customers using ADM (Atellica Data Manager), contact your local Siemens
support representative to create a rule for the RCRP assay to convert a “No
Calculation” flag to a <0.05 mg/dL (<0.5 mg/L) result.
2. For customers not using ADM, RCRP test results that produce a “No Calculation”
flag can be reported as <0.05 mg/dL (<0.5 mg/L).
• Please retain this letter with your laboratory records and forward this letter to those who
may have received this product.
Resolution The resolution for the “No Calculation” flag on samples with CRP concentrations <0.05 mg/dL
(<0.5 mg/L) is implemented in the upcoming Atellica Solution Software (SW) v1.29.
Single Registration
US-MF-000016560
Number (SRN)

We apologize for the inconvenience this situation may cause. If you have any questions, please contact your
Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Atellica is a registered trademark of Siemens Healthcare Diagnostics Inc. © Siemens Healthcare Diagnostics Inc. 2024

Siemens Healthineers
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591
[Link]

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