Integra Licox Test Kit REF BC10R Rx Only An accessory provided for… — Class II medical device recall Z-1675-2014
Terminated recall by Integra LifeSciences Corp., reported 2014-06-11, distributed in FL, IL, MA, MD, NC, PA, SD. Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test K
| Recall number | Z-1675-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-05-30 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-10-24 |
| Distributed | FL, IL, MA, MD, NC, PA, SD |
| Countries outside the US | AT, AU, BE, CL, DE, FI, GB, GR, IL, IT, RU |
| Quantity | 49 test |
| Lot numbers | 051113, 100913, 140513, 161013, 25013 |
| Model numbers | BC10R |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1675-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.