Optilite IgM Kit (2019-07-19)

Starting date:

July 19, 2019

Posting date:

August 16, 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-70729

Last updated: 2019-08-16

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  Reason
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  Affected products

Affected Products

Optilite IgM Kit

Reason

For specific kits results may be reported outside of the acceptable range 3 hours following initial calibration leading to rejection of the calibration curve and an associated delay in testing.

Affected products