FDA Device recall Z-2230-2025
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack) by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2230-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-26 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Reason
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.
Identifiers
| code_info | Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2025%22
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