Class II — Siemens Healthcare Diagnostics Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813 |
| Quantity | 0 cartridges US |
| Distribution | Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Cambodia Canada Chile China Colombia Congo, Republic Costa Rica Cte dIvoire Croatia Curaao Czech Republic Denmark Ecuador Egypt Estonia Fiji Finland France French… |
| Initiated | 2023-10-26 |
| Classified | 2023-12-21 |
| Recall number | Z-0606-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics Inc (Z-0606-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93473/
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