Elecsys CA 19-9 (2020-02-10)

Starting date:

February 10, 2020

Posting date:

March 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72489

Last updated: 2020-03-10

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  Reason
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  Affected products

Affected Products

Elecsys CA 19-9

Reason

An increased number of complaints concerning non-reproducible elevated results (so-called "high flyers") were confirmed for Elecsys CA 19-9 assay used on cobas e 801 instrument only.

Affected products