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 require immediate action to prevent potential harm.
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 risks by delaying diagnosis of sodium imbalances. If the true sodium level is near critical thresholds, this could lead to dangerous conditions like hypernatremia or hyponatremia.
The cartridges may cause the sodium sensor to produce a negative bias, leading to delayed diagnosis of hypernatremia (high sodium) or unnecessary treatment for hyponatremia (low sodium). This risk is highest when sodium levels are near critical thresholds, potentially causing dangerous conditions like iatrogenic hypernatremia.
Healthcare providers using the RAPIDPoint 500 Systems for blood tests are most at risk. Patients with sodium levels near critical thresholds could face serious health consequences if the cartridge causes delayed diagnosis.
The affected cartridges have the model name 'RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400' and are identified by serial numbers starting with '10491448' or '00630414589763'. They were sold for in vitro diagnostic use in blood testing.
Look for serial numbers starting with '10491448' or '00630414589763' on the cartridge.
The cartridges may cause delayed diagnosis of hypernatremia (high sodium) or hyponatremia (low sodium), leading to serious health risks like iatrogenic hypernatremia if sodium levels are near critical thresholds.
The affected cartridges have the model name 'RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400' and serial numbers starting with '10491448' or '00630414589763'.
The recall does not specify an immediate stop; however, healthcare providers should check their cartridges for the serial numbers listed and take action if they are affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0608-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0608-2024 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.
