FDA Device recall Z-1675-2014
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors by Integra Lifesciences, citing 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 fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1675-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-16 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | FL, IL, MA, MD, NC, PA, SD |
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.
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).
Identifiers
| code_info | Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2014%22
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