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Atellica system
Official notice
14 Mar 2022
Last checked
14 Mar 2022
An official Health Canada notice concerns Atellica system. Siemens Healthcare Diagnostics Inc. Has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the instructions for use (IFU). Limited data is available at this time as the investigation for this issue is on-going. Recall start date: Mar 9, 2022 Published 2022-03-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63995
Official notice
2022-03-14
The hazard
The hazard
Siemens Healthcare Diagnostics Inc. Has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the instructions for use (IFU). Limited data is available at this time as the investigation for this issue is on-going. Recall start date: Mar 9, 2022
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.
Recall Numbers
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Affected products
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Risk / hazard
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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Siemens, Atellica System.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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