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Dimension vista system - ca15-3 flex reagent cartridge
Official notice
25 Jul 2022
Last checked
25 Jul 2022
An official Health Canada notice concerns Dimension vista system - ca15-3 flex reagent cartridge. Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias for the lots listed range from -26% to -33%. Patient bias is consistent across the analytical measurement range (AMR). The highest bias observed on a patient sample (56 u/ml) was - 47%. Quality control does not detect this issue Recall start date: July 26, 2022 Published 2022-07-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64403
Official notice
2022-07-25
The hazard
The hazard
Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias for the lots listed range from -26% to -33%. Patient bias is consistent across the analytical measurement range (AMR). The highest bias observed on a patient sample (56 u/ml) was - 47%. Quality control does not detect this issue Recall start date: July 26, 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 Vista System - Ca15-3 Flex Reagent Cartridge.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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