Integra Licox Test Kit Recall for Erroneous Calibration Messages
Integra LifeSciences is recalling Licox Test Kits that may display false calibration failure messages or out-of-range results when used with specific PtO2 monitors.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves erroneous diagnostic messages rather than direct physical injury or contamination, fitting the criteria for moderate severity involving low-risk functional defects.
Plain-English summary
Integra LifeSciences Corp. is recalling 49 Licox Test Kits (Catalog Number BC10R) due to a potential defect. The company identified through a small number of complaints that some lot numbers of these test kits may provide erroneous "calibration test failure" messages when used with the Licox PtO2 Monitor (LCSO2). Additionally, the kits may provide erroneous out-of-range results when used with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).
The affected test kits are accessories used to verify the state of calibration of the monitors. The recall includes specific lot numbers: 051113, 100913, 140513, 161013, and 25013. The products were distributed worldwide, including in the United States (Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, and South Dakota) and internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy, and Russia.
Users should check their Licox Test Kits for the affected catalog number and lot numbers listed above. If the product matches the recall description, users should stop using the test kits and contact Integra LifeSciences for further instructions.
The recalled product
- 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 elec
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Number BC10R Lot Nos: 051113
- 100913
- 140513
- 161013
- 25013
Distribution
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