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Dimension vista® system - total bilirubin assay
Official notice
21 Aug 2024
Last checked
21 Aug 2024
An official Health Canada notice concerns Dimension vista® system - total bilirubin assay. Siemens Healthineers has confirmed, through investigation of customer complaints, the potential for discordant total bilirubin (tbil) results when the last three tests from the 160 test flex of lot 23206bA (wells 8 or 10) were processed on the Dimension Vista® platform. Calibrator, quality control and patient results could be impacted. The impact is variable across the analytical measurement range. This issue is isolated only to a portion of the flex lot therefore, the probability of occurrence of a discordant tbil result was determined to be 1%. Results could be erroneously increased or depressed due to the uncertain delivery of reagents from underfilled wells into the reaction cuvette. Recall start date: August 6, 2024 Published 2024-08-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75954
Official notice
2024-08-21
The hazard
The hazard
Siemens Healthineers has confirmed, through investigation of customer complaints, the potential for discordant total bilirubin (tbil) results when the last three tests from the 160 test flex of lot 23206bA (wells 8 or 10) were processed on the Dimension Vista® platform. Calibrator, quality control and patient results could be impacted. The impact is variable across the analytical measurement range. This issue is isolated only to a portion of the flex lot therefore, the probability of occurrence of a discordant tbil result was determined to be 1%. Results could be erroneously increased or depressed due to the uncertain delivery of reagents from underfilled wells into the reaction cuvette. Recall start date: August 6, 2024
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Brand: Siemens, Dimension Vista® System - Total Bilirubin Assay.
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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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