CRP Vario and Alinity C CRP Vario Reagent Kit (2019-11-13)

Starting date:

November 13, 2019

Posting date:

January 6, 2020

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-71981

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

A. CRP Vario

B. Alinity C CRP Vario Reagent Kit

Reason

Package insert of the CRP Vario assays list the EDTA as a suitable anticoagulant for the sampling collection tube. Recent testing results showed that the edta sample tube storage claims for dipotassium and tripotassium EDTA at 2-8°C and 20-25°C are not met. Therefore the EDTA sample tube is no longer appropriate to use

Affected products