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RAPIDPoint 500 Measurement CartridgeRecalls & reported problems across all models

Siemens Healthcare Diagnostics Inc. · 4 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

4 open recalls name at least one RAPIDPoint 500 Measurement Cartridge model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls
4

We found 4 models of RAPIDPoint 500 Measurement Cartridge by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2021 and Aug 23, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RAPIDPoint 500 Measurement Cartridge recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Oct 26, 2023Class IIOpen, Classified

    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.

    Z-0609-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Oct 26, 2023Class IIOpen, Classified

    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.

    Z-0608-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Oct 26, 2023Class IIOpen, Classified

    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.

    Z-0607-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  4. Oct 26, 2023Class IIOpen, Classified

    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.

    Z-0606-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported RAPIDPoint 500 Measurement Cartridge problems

Device problems

  • High Test Results1
  • Low Test Results1
  • Non Reproducible Results1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

RAPIDPoint 500 Measurement Cartridge models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent RAPIDPoint 500 Measurement Cartridge adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Siemens Healthcare Diagnostics Inc. products

All Siemens Healthcare Diagnostics Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page