RAPIDPoint® 500 Measurement Cartridge 10491449Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414589770), 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).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K122398); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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 ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 23, 2022High Test Results; High Test Results

  CUSTOMER REPORTED THEIR RP500E GENERATED A DISCREPANT HIGH THB (TOTAL HEMOGLOBIN) RESULT COMPARED TO THE RESULT FROM RETESTING THE SAME SAMPLE ON THE SAME ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275979 ↗
• MalfunctionAug 19, 2022Low Test Results; Low Test Results

  CUSTOMER REPORTED A DISCREPANT LOW THB (TOTAL HEMOGLOBIN) RESULT GENERATED ON THE RP500 COMPARED TO THE THB RESULT OF A DIFFERENT SAMPLE ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258013 ↗
• MalfunctionMar 4, 2021Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE RP500E WHEN COMPARED TO REPEAT TESTING WITH THE SAME SAMPLE ON THE SAME INSTRUMENT. THE CUSTOMER DOES NOT KNOW WHICH IS THE CORRECT RESULT. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417687 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122398. One submission often covers many models, so check the product and lot details in each record.

• Z-0608-2024 · Oct 26, 2023 · Open, Classified
  RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
• Z-0607-2024 · Oct 26, 2023 · Open, Classified
  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
• Z-0606-2024 · Oct 26, 2023 · Open, Classified
  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