Dimension Vista Cyclosporine System (CSA) Assay (2019-07-02)

Starting date:

July 2, 2019

Posting date:

July 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70427

Last updated: 2019-07-15

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  Reason
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  Affected products

Affected Products

Dimension Vista Cyclosporine System (CSA) Assay

Reason

Siemens Healthcare Diagnostics has confirmed the Dimension Vista Cyclosporine (CSA) Flex reagent cartridge lots listed may produce Abnormal Assay flags when processing calibration, quality control (QC) or patient samples. A Dimension Vista Abnormal Assay flag may be generated dependent on instrument specific photometrics and the CSA reagent lot in use. Siemens internal testing has found that the frequency of Abnormal Assay flags could be up to 50% on some Dimension Vista systems. The Dimension Vista Operator's Guide states results cannot be reported if an Abnormal Assay flag is generated and to rerun the sample.

Affected products