Z-1675-2014Class II

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

Name: Z-1675-2014 Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors...
Creator: Integra LifeSciences Corp.
Published: 2014-04-16
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-04-16 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2014-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1675-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-05-30
Terminated: 2014-10-24
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GWM Device, Monitoring, Intracranial Pressure
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).
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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, Germany, Great Britain, Greece, Israel, Italy and Russia.
Product codes and lots: Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-05-30

Product code GWM

K131184Class IIIntegra Licox Pto2 MonitorIntegra Lifesciences Corp. / cleared 2013-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)