Siemens Healthcare recalls RAPIDPoint 500 Wash/Waste Cartridges (Lot WW/08925) due to potential patient treatment delays from inaccurate lab results. Affected units may cause errors in calcium, potassium, and other critical tests.
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
Siemens Healthcare is recalling RAPIDPoint 500 Wash/Waste Cartridges (4 Pack) with Lot WW/08925 because a manufacturing error can cause lab test errors. This might delay patient treatment or cause temporary health issues if not caught during quality checks.
The cartridges have a manufacturing error that causes inaccurate lab results for critical tests like calcium, potassium, pH, and glucose. If these errors aren't caught during quality checks, they could delay patient treatment or cause temporary health issues.
Laboratory users who operate the RAPIDPoint 500 Systems are affected. Patients receiving lab tests using these cartridges may experience temporary treatment delays or health issues if errors go undetected.
Check for the Lot Number WW/08925 on the cartridge packaging. The product was sold with Material Number 10329097 and GTIN 00630414482163.
Review lab results for potential inaccuracies in calcium, potassium, pH, chloride, pCO2, glucose, and lactate tests.
Ask your lab provider if they have the affected lot number WW/08925 and whether they need to replace cartridges.
Siemens Healthcare identified a manufacturing error in the RAPIDPoint 500 Wash/Waste Cartridges that can cause inaccurate lab results for critical tests.
The recall states that errors could lead to temporary health issues if not caught during quality checks, but no serious injuries have been reported.
Check for Lot Number WW/08925 on the cartridge packaging. The product has Material Number 10329097 and GTIN 00630414482163.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2230-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2230-2025 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.
