Siemens Healthcare recalls RAPIDLab 1265 Blood Gas Analyzers with serial numbers 110321852, 10470366, 10491395 due to potential hydroxocobalamin interference causing inaccurate blood gas readings, which could affect patient treatment decisions.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
Siemens Healthcare is recalling specific models of RAPIDLab 1265 Blood Gas Analyzers because certain therapeutic levels of hydroxocobalamin in the blood can cause inaccurate blood gas readings. This interference might lead to incorrect medical assessments and potentially withhold necessary treatments or stop medications.
The blood gas analyzer may produce inaccurate results when blood samples contain therapeutic levels of hydroxocobalamin (1mg/mL or 2mg/mL). This can cause the device to report lower than expected carboxyhemoglobin and methemoglobin levels, potentially leading to incorrect medical decisions about patient care.
Healthcare facilities using the recalled RAPIDLab 1265 Blood Gas Analyzers with serial numbers 110321852, 10470366, or 10491395 are most at risk. Patients receiving blood gas tests through these devices could be affected if their blood contains therapeutic levels of hydroxocobalamin.
Check for the serial numbers 110321852, 10470366, or 10491395 on the RAPIDLab 1265 Blood Gas Analyzer. The device is a point-of-care system used for blood gas and other lab tests at the patient's bedside.
Identify if your device has serial numbers 110321852, 10470366, or 10491395.
The blood gas analyzer may produce inaccurate results when blood samples contain therapeutic levels of hydroxocobalamin (1mg/mL or 2mg/mL), which could lead to incorrect medical assessments and treatment decisions.
Patients receiving blood gas tests through the recalled device might receive incorrect results if their blood contains therapeutic levels of hydroxocobalamin, potentially affecting treatment decisions.
The recall record does not mention any remedy or corrective action for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2930-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2930-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
