Integra LifeSciences Corp.: Medical Device Recall in 2014 - (Recall #: Z-1675-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 16, 2014

Date Posted: June 11, 2014

Recall Number: Z-1675-2014

Event ID: 68159

Reason for Recall:

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).

Status: Terminated

Product Quantity: 49 test probes

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.

Voluntary or Mandated:

Voluntary: Firm initiated