Human IgM kit for use on SPAPLUS (2018-10-23)

Starting date:

October 23, 2018

Posting date:

November 15, 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-68232

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  Reason
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  Affected products

Affected products

Human IgM kit for use on SPAPLUS

Reason

Customer complaints have identified calibration issues with control results reporting out of range for this kit lot, leading to frequent recalibration of the assay. Customers have reported control results outside the acceptance range after first calibration or a few days later. This was confirmed through internal investigations and action to initiate a product correction was agreed by the binding site on 15th October 2018 to allow continued use of the product.

Affected products