Health product recall

Dimension Vista System - Ca15-3 Flex Reagent Cartridge

Last updated

Summary

Product
Dimension Vista System - Ca15-3 Flex Reagent Cartridge
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalogue number

Dimension Vista System - Ca15-3 Flex Reagent Cartridge

21340BB

10464344

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

Siemens Healthcare Diagnostics Inc.

500 Gbc Drive, Newark, Delaware, United States, 19714

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64403

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