Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provide

FDA device recall Z-1675-2014 · posted 2014-05-30 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

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).

Action taken

Integra sent an "Urgent Voluntary Medical Device Recall/Return Response form notifications dated April 16, 2014 to US customers via traceable courrier service and to non-US customers via traceable email or facsimile. The customer notification advises them of the nature of the issue and the potential for adverse patient consequences; advises them to review their inventory and if they have BC10R Test Kit Resistors with an affected lot number to immediately stop using it; requests they identify and report to Integra if they do or do not have any affected BC10R affected lot numbers; and advises them how to return any affected products in their possession. Customers with questions were instructed to call 1-855-532-1723.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GWM

Quantity affected

49 test probes

Distribution

Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, German

Date initiated

2014-04-16

Date posted

2014-05-30

Date terminated

2014-10-24

Location

Plainsboro, NJ

Related 510(k) clearances