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Atellica ch 930 analyzer
Official notice
7 Dec 2021
Last checked
7 Dec 2021
An official Health Canada notice concerns Atellica ch 930 analyzer. Siemens Healthcare Diagnostics has identified issues with the Atellica CH 930 Analyzer, which are installed with Atellica solution software (SW) versions V1.25.1 and lower when using open channelassays. Siemens Healthineers assays are not impacted. Issue 1: TDEF (test definition) parameters for open channel assays reverting to default values. If TDEF parameters have been edited for an open channel assay under the CH test definition screen, the next time an open channel configuration screen is edited, it may overwrite the previously edited open channel TDEF parameters on the CH test definition screen with default values. Issue 2: On board stability (OBS) not updating with manual changes. When the customer manually changes the onboard stability (OBS). For reagent packs for open channel assays, the operator will only see a change for reagent 1-Well-1 with no change to R1-Well-2, R2-Well-1, and R2-Well-2. The system may continue to use the reagent past its OBS date leading to potential erroneous patient sample results. Recall start date: Nov 24, 2021 Published 2021-12-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63690
Official notice
2021-12-07
The hazard
The hazard
Siemens Healthcare Diagnostics has identified issues with the Atellica CH 930 Analyzer, which are installed with Atellica solution software (SW) versions V1.25.1 and lower when using open channelassays. Siemens Healthineers assays are not impacted. Issue 1: TDEF (test definition) parameters for open channel assays reverting to default values. If TDEF parameters have been edited for an open channel assay under the CH test definition screen, the next time an open channel configuration screen is edited, it may overwrite the previously edited open channel TDEF parameters on the CH test definition screen with default values. Issue 2: On board stability (OBS) not updating with manual changes. When the customer manually changes the onboard stability (OBS). For reagent packs for open channel assays, the operator will only see a change for reagent 1-Well-1 with no change to R1-Well-2, R2-Well-1, and R2-Well-2. The system may continue to use the reagent past its OBS date leading to potential erroneous patient sample results. Recall start date: Nov 24, 2021
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Siemens, Atellica Ch 930 Analyzer.
Source & status
Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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