Device product
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
Z-1675-2014
Product summary
- Event
- Event 68159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 test probes
- Official record key
device-enforcement:Z-1675-2014
Official wording
Reason: Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).
Code information: Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013
Distribution pattern: Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.
Derived failure modes
-
Unknown
Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).