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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637
“Siemens Healthcare RAPIDPoint 500 Wash/Waste Cartridge Recall: Risk of Patient Treatment.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51958-siemens-healthcare-rapidpoint-500-wash-waste-cartridge-recall-risk-of. Based on FDA recall #Z-2230-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2025%22&limit=1).
The FDA announced on June 26, 2025, that Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 500 Systems Wash/Waste Cartridges due to a manufacturing error causing biased test results. Use of the affected device may result in errors during quality control which could lead to a delay in patient treatment.
How to tell if you have it
Brand: Siemens Healthcare
Product: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
Material Number: 10329097
UPC: 00630414482163
Lot Number: WW/08925
Expiration Date: 12/03/2025
The hazard
The recall is 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. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) recall (Aug. 17, 2026), Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include GEM Premier 5000 Cartridges May Cause Errors During Warm-Up (Jan. 20, 2026) and Medtronic HR-ACT Cartridges Recall (Oct. 20, 2025).
How to tell if you have this one
Check for the Lot Number WW/08925 on the cartridge packaging. The product was sold with Material Number 10329097 and GTIN 00630414482163.
Brand
Siemens Healthcare
Product
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Errors
Review lab results for potential inaccuracies in calcium, potassium, pH, chloride, pCO2, glucose, and lactate tests.
Contact Lab Provider
Ask your lab provider if they have the affected lot number WW/08925 and whether they need to replace cartridges.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2230-2025 (June 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2230-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.