Siemens Healthcare recalls RAPIDPoint 500 Systems Measurement Cartridges with lactate that may cause delayed diagnosis of hypernatremia or hyponatremia, leading to serious health risks. Affected units have specific serial numbers.
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.
Siemens Healthcare is recalling RAPIDPoint 500 Systems Measurement Cartridges with lactate because they can cause serious health issues by delaying diagnosis of sodium imbalances. This risk is highest for patients with critical sodium levels near dangerous thresholds.
The cartridges can cause the sodium sensor to give false low readings, which may delay treatment for high sodium levels (hypernatremia) or cause unnecessary treatment for low sodium levels (hyponatremia). This risk is especially dangerous when sodium levels are near critical thresholds.
Healthcare facilities using the RAPIDPoint 500 systems for blood tests are most at risk. Patients with critical sodium levels near dangerous thresholds face the highest risk of serious injury.
Check for the RAPIDPoint 500 Systems Measurement Cartridges with lactate. Affected units have serial numbers starting with 10491447 or 00630414589756.
Look for serial numbers starting with 10491447 or 00630414589756 on the cartridge.
The cartridges can cause the sodium sensor to give false low readings, which may delay treatment for high sodium levels or cause unnecessary treatment for low sodium levels, especially when sodium levels are near critical thresholds.
Patients with critical sodium levels near dangerous thresholds may face serious health risks if the cartridges are used without correction.
Check the serial number on the cartridge; affected units have serial numbers starting with 10491447 or 00630414589756.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0607-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0607-2024 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.
