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Dimension exl system - cardiac troponin-i (ctni) assay
Official notice
13 Jun 2022
An official Health Canada notice concerns Dimension exl system - cardiac troponin-i (ctni) assay. Siemens Healthcare Diagnostics Inc. Has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml. Troponin values as high as 0.20 ng/ml have been observed with lithium heparin plasma that are expected to be within the 99th percentile. Serum samples collected from normal, healthy individuals whose results fall within the reference interval or below the 99th percentile of 0.07 ng/ml were not impacted by this issue. Recall start date: May 24, 2022 Published 2022-06-13.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64256
Official notice
2022-06-13
The hazard
The hazard
Siemens Healthcare Diagnostics Inc. Has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml. Troponin values as high as 0.20 ng/ml have been observed with lithium heparin plasma that are expected to be within the 99th percentile. Serum samples collected from normal, healthy individuals whose results fall within the reference interval or below the 99th percentile of 0.07 ng/ml were not impacted by this issue. Recall start date: May 24, 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.
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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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Brand: Siemens, Dimension Exl System - Cardiac Troponin-i Assay.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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