Approximately 27,127 Radiometer ABL800 FLEX blood gas analyzers are being recalled due to a defect where bacteria may grow within the calibration solution bottles. This bacterial growth causes the pH level of the solution to decrease, which can lead the analyzer to report inaccurate or biased pH results for patient blood samples. These analyzers are commonly used in clinical settings for testing whole blood, expired air, and pleura samples. Consumers and healthcare providers should contact the manufacturer or their healthcare representative for guidance on corrective actions and next steps.
Bacterial contamination in the calibration solution can alter its chemical balance, causing the machine to provide out-of-specification pH readings. Inaccurate blood gas results could lead to incorrect medical diagnoses or inappropriate treatment decisions for patients in critical care.
Manufacturer initiated notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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