Human IgM kit for use on SPAPLUS (2018-07-25)

Starting date:

July 25, 2018

Posting date:

August 2, 2018

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-67356

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  Reason
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  Affected products

Affected products

Human IgM kit for use on SPAPLUS

Reason

Following the receipt of an external complaint a review was held at the binding site on 13/07/2018. Investigations at the binding site indicate that after running the calibration curve the recovery of the kit control results decrease by approximately 12% within the same day. Samples have been shown to be similarly affected.

Affected products