Health product recall

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

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

FilmArray Meningitis/Encephalitis (ME) Panel

Lot or serial number

580818

Model or catalog number

RFIT-ASY-0118

Companies
Manufacturer
BioFire Diagnostics, LLC
515 Colorow Dr
Salt Lake City
84108
Utah
UNITED STATES