RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
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