Dimension Vista System - Ca15-3 Flex Reagent Cartridge
Brand(s)
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
Get notified
Receive emails about new and updated recall and safety alerts.