DC Screening II (2019-09-18)

Starting date:

September 18, 2019

Posting date:

November 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-71591

Last updated: 2019-11-15

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  Reason
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  Affected products

Affected Products

DC Screening II

Reason

An internal study revealed that lot 50560 94 02 DC-Screening ID-cards exhibited decreased reaction intensity in samples known to contain red blood cells with small amounts of C3d (C3b). This situation can potentially lead to false negative results in samples containing red cells with small amounts of C3d / C3b on their surface only (not IgG).

Affected products