Ceruloplasmln assay, Alinity c Ceruloplasmin Reagent Kit (2019-06-28)

Starting date:

June 28, 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-70423

Last updated: 2019-07-15

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  Reason
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  Affected products

Affected Products

A. Ceruloplasmln assay

B. Alinity c Ceruloplasmin Reagent Kit

Reason

Package insert of the ceruloplasmin assay lists the EDTA as suitable anticoagulant for sampling collection tube. However, the EDTA sample tube storage claims are not met with the new studies performed. In particular, the stability claims of 2 weeks at 2-8 degrees celsius and 8 days at room temperature are not confirmed, both for dipotassium and for tripotassium EDTA.

Affected products