| 2024-11-20 |
Class I
|
Ongoing |
Z-0683-2025 |
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket… |
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A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data manage… |
| 2024-11-20 |
Class I
|
Ongoing |
Z-0682-2025 |
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter… |
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A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data manage… |
| 2024-11-20 |
Class I
|
Ongoing |
Z-0681-2025 |
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati… |
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A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's … |
| 2023-09-18 |
Class II
|
Ongoing |
Z-0208-2024 |
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,… |
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Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri… |
| 2023-09-18 |
Class II
|
Ongoing |
Z-0207-2024 |
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an… |
— |
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri… |