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Vidas high sensitive troponin i (tnhs)
Official notice
21 Feb 2022
Last checked
21 Feb 2022
An official Health Canada notice concerns Vidas high sensitive troponin i (tnhs). Since January 2021, based on complaints received from the field related to critical non-repeatable overestimated results (changing interpretation according to the cutoff value, 19 ng/l, in the frame of the three hours algorithm that lead to a change in clinical interpretation) that lead to false positive results by some customers, Biomérieux initiated an investigation that is still ongoing. It is important to keep in mind that it is commonly acknowledged among experts that both conventional and high sensitive troponin assays can lead to abnormally non-repeatable overestimated values especially in the lower part of the measuring range. Recall start date: Jan 31, 2022 Published 2022-02-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63938
Official notice
2022-02-21
The hazard
The hazard
Since January 2021, based on complaints received from the field related to critical non-repeatable overestimated results (changing interpretation according to the cutoff value, 19 ng/l, in the frame of the three hours algorithm that lead to a change in clinical interpretation) that lead to false positive results by some customers, Biomérieux initiated an investigation that is still ongoing. It is important to keep in mind that it is commonly acknowledged among experts that both conventional and high sensitive troponin assays can lead to abnormally non-repeatable overestimated values especially in the lower part of the measuring range. Recall start date: Jan 31, 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
Product 1
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: Biomerieux, Vidas High Sensitive Troponin I.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
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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