ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay (2019-11-21)

Starting date:

November 21, 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-71989

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay

Reason

Recall due to current assigned values for ADVIA Chemistry HSCRP Calibrator lot 453610 demonstrate a positive bias of approximately 11% for HSCRP patient samples and quality control material when compared to the European reference material ERM da474/IFCC for CRP measurement.

Affected products