Siemens Healthcare recalls RAPIDPoint 405 Blood Gas Analyzers with specific serial numbers due to hydroxocobalamin interference causing inaccurate blood gas readings, which may 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 RAPIDPoint 405 Blood Gas Analyzers because certain therapeutic levels of hydroxocobalamin can cause inaccurate blood gas readings. This could lead to incorrect medical assessments and potentially withhold necessary treatments or cause unnecessary medication changes.
The device can produce inaccurate blood gas measurements when hydroxocobalamin levels in the patient's blood reach 1mg/mL or 2mg/mL. This interference may lead to incorrect assessments of carboxyhemoglobin and methemoglobin levels, potentially affecting treatment decisions.
Healthcare providers using the RAPIDPoint 405 Blood Gas Analyzers with the listed serial numbers are affected. Patients receiving blood gas tests through these devices may be at risk if the interference causes inaccurate results.
Check the serial number on your RAPIDPoint 405 Blood Gas Analyzer. The affected units include specific serial numbers listed in the recall notice.
Identify the serial number on your RAPIDPoint 405 Blood Gas Analyzer to determine if it is affected.
The recall occurs because hydroxocobalamin levels in some patients' blood can interfere with the device's measurements, leading to inaccurate blood gas results.
Inaccurate results could lead to incorrect medical assessments, potentially withholding necessary treatments or causing unnecessary medication changes.
Check the serial number on your RAPIDPoint 405 Blood Gas Analyzer; affected units have specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2927-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2927-2018 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.
