FilmArray Meningitis/Encephalitis (ME) Panel (2018-09-20)

Starting date:

September 20, 2018

Posting date:

November 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-68170

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  Reason
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  Affected products

Affected products

FilmArray Meningitis/Encephalitis (ME) Panel

Reason

This Field Safety Corrective Action (FSCA) has been initiated due to an issue identified in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the FilmArray ME Panel.

Affected products