Siemens Healthcare recalls RAPIDLab 1245 Blood Gas Analyzers due to potential incorrect blood test results from hydroxocobalamin interference. Affected units may show lower carboxyhemoglobin and methemoglobin levels, risking wrong medical 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 RAPIDLab 1245 Blood Gas Analyzers because certain hydroxocobalamin levels in patient blood can cause the device to report inaccurate carboxyhemoglobin and methemoglobin levels. This could lead to incorrect medical decisions, such as stopping necessary treatments or delaying care.
The device may report lower than actual carboxyhemoglobin and methemoglobin levels when patient blood contains therapeutic levels of hydroxocobalamin (1mg/mL or 2mg/mL). This could cause doctors to stop necessary treatments or delay critical care based on incorrect test results.
Healthcare providers using the RAPIDLab 1245 Blood Gas Analyzer for blood tests are affected. Patients with specific blood conditions may be at risk if the device gives incorrect results.
Check for the model numbers 10321844, 10337179, or 10491393 on the RAPIDLab 1245 Blood Gas Analyzer. The device is a point-of-care blood testing system used in hospitals and clinics.
Verify the model number on your RAPIDLab 1245 Blood Gas Analyzer to confirm if it is affected (10321844, 10337179, or 10491393).
The device may report inaccurate carboxyhemoglobin and methemoglobin levels when patient blood contains therapeutic levels of hydroxocobalamin (1mg/mL or 2mg/mL), which could lead to incorrect medical decisions.
Check the model number on your device. If it matches 10321844, 10337179, or 10491393, contact Siemens Healthcare for guidance.
The recall record does not mention a remedy or fix 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-2929-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2929-2018 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.
