Health product recall

Xpert Xpress Flu/RSV (2019-10-07)

Starting date:
October 7, 2019
Posting date:
November 1, 2019
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-71463



Last updated: 2019-11-01

Affected Products

Xpert Xpress Flu/RSV

Reason

A limited number of reports were received from customers who experienced a higher than expected frequency of '5011' (signal loss detected or sSLD) error events.

Affected products

Xpert Xpress Flu/RSV

Lot or serial number

28113

28204

28205

28302

Model or catalog number

XPRSFLU/RSV-10

Companies
Manufacturer

Cepheid

904 Caribbean Drive

Sunnyvale

94089

California

UNITED STATES