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Health product recall

MiSeqDx Instrument (2017-10-05)

Starting date:
October 5, 2017
Posting date:
October 13, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, General Public, Healthcare Professionals
Identification number:
RA-64850

Affected products

MiSeqDx Instrument

Reason

Potential for Varistor component to be missing in power supply. No potential for discrepant results or misdiagnosis. Worst case scenario would a delay of results from loss of power.

Affected products

MiSeqDx Instrument

Lot or serial number

More than 10 numbers, contact manufacturer.  

Model or catalog number

DX-410-1001

Companies
Manufacturer
ILLUMINA, INC.
5200 ILLUMINA WAY
San Diego
92122
California
UNITED STATES