Siemens Healthcare recalls RAPIDPoint 500 Systems Measurement Cartridges with lactate due to potential sodium sensor errors that could delay diagnosis of hypernatremia or cause unnecessary hyponatremia treatment. Affected units may show Question Result errors.
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 might cause sodium sensor errors. This could lead to delayed diagnosis of high sodium levels or unnecessary treatment for low sodium levels, risking serious health issues.
The cartridges may cause the sodium sensor to give false low readings, which could delay detecting high sodium levels (hypernatremia) or trigger unnecessary treatment for low sodium levels (hyponatremia). This risk is highest when sodium results are near critical thresholds.
Healthcare facilities using the RAPIDPoint 500 Systems for blood tests are most at risk. Patients with sodium levels near critical thresholds could face delayed treatment or incorrect diagnoses.
Check for the RAPIDPoint 500 Systems Measurement Cartridges with lactate. The product has serial numbers starting with SMN: 10844813 and UDI-DI: 00630414947556.
Look for serial numbers starting with SMN: 10844813 or UDI-DI: 00630414947556 on the cartridge packaging.
The cartridges may cause the sodium sensor to produce false low readings, which could delay diagnosis of hypernatremia (high sodium) or cause unnecessary treatment for hyponatremia (low sodium).
Check for serial numbers starting with SMN: 10844813 or UDI-DI: 00630414947556 on the cartridge packaging.
No, but you should check the serial numbers to confirm if your cartridges are affected. The recall does not require immediate discontinuation but requires verification.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0606-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0606-2024 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.
