CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
RAPIDPoint 500 Systems Wash/Waste Cartridge recalled
Siemens Healthcare Diagnostics is recalling RAPIDPoint 500 Systems Wash/Waste Cartridge, distributed nationwide in the US. The recall was initiated on 26 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2230-2025
- FDA event ID
- 97209
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2025
- FDA classified
- 31 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Jun 2025 | Recall initiated by company | |
| 31 Jul 2025 | Classified by FDA | +35 days |
| 6 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Where it was distributed
worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.
Where was it sold?
worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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