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Tomcat Instrument
- Starting date:
- June 28, 2017
- Posting date:
- August 14, 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-64156
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