This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Tomcat Instrument

Starting date:
June 28, 2017
Posting date:
August 15, 2017
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-64208

Reason

Periodically fail sample processing due to E18-excessive sample volume errors. Root cause has been attributed to no x-axis holding force during the pipettor homing routine which can cause incorrect homing of the pipettor z-axis. Software anomaly which, in rare cases, can impact the tomcat's pipettor arm, causing the sample pipette tip position to offset slightly lower than normal.

Affected products

Tomcat Instrument

Lot or serial number

SN TC00000291

Model or catalog number

TOMCAT INSTRUMENT

Companies

Manufacturer
Gen-Probe Incorporated, a wholly owned subsidiary of Hologic, Inc.,
10210 Genetic Center Drive,
San Diego.
92121
California
UNITED STATES