Siemens Healthcare recalls RAPIDPoint 500 Blood Gas Analyzers with specific serial numbers due to potential 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 500 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 stop medications.
The device can produce inaccurate blood gas measurements when hydroxocobalamin (a vitamin B12 form) is present at therapeutic levels of 1mg/mL or 2mg/mL. This interference may cause falsely low carboxyhemoglobin and methemoglobin readings, which could lead to incorrect medical decisions.
Healthcare providers using the RAPIDPoint 500 Blood Gas Analyzers with the listed serial numbers are most at risk. Patients receiving blood gas testing through these devices may be affected if the interference occurs.
Check for the serial numbers 10492730, 1069855, 10696857, or 10697306 on the RAPIDPoint 500 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 RAPIDPoint 500 Blood Gas Analyzer has one of the serial numbers: 10492730, 1069855, 10696857, or 10697306.
The recall is due to hydroxocobalamin at therapeutic levels (1mg/mL or 2mg/mL) potentially interfering with blood gas measurements, which could lead to inaccurate patient assessments.
Patients receiving blood gas testing with the affected devices may receive incorrect results, which could impact treatment decisions. Healthcare providers should verify results with alternative methods.
The official recall does not provide a fix; affected devices must be checked for the specific serial numbers and may need to be replaced or adjusted by healthcare providers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2928-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2928-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
