Walham, MA, US · 11 510(k) clearances · 5 recalls (3 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | Class II | Clinical Chemistry | 2 | 2026-01-09 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | Class II | Clinical Chemistry | 2 | 2023-09-29 |
| CGA | Glucose Oxidase, Glucose | Class II | Clinical Chemistry | 2 | 2022-10-18 |
| SHB | Creatinine Test System For At Home Prescription Use | Class II | Clinical Chemistry | 1 | 2026-01-21 |
| LCP | Assay, Glycosylated Hemoglobin | Class II | Hematology | 1 | 2024-11-22 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | Class II | Clinical Chemistry | 1 | 2024-02-23 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical Chemistry | 1 | 2020-04-14 |
| GGZ | Oxyhemoglobin | Class II | Hematology | 1 | 2020-04-06 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 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… | — | 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… | — | 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… | — | 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,… | — | 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… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-21 | K251281 | Nova Max Creat eGFR Monitoring System | SHB | Class II | Clinical Chemistry |
| 2026-01-09 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | Class II | Clinical Chemistry |
| 2024-11-22 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | LCP | Class II | Hematology |
| 2024-11-19 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | Class II | Clinical Chemistry |
| 2024-02-23 | K232075 | StatStrip Glucose Hospital Meter System | PZI | Class II | Clinical Chemistry |
| 2023-09-29 | K221900 | Stat Profile Prime Plus Analyzer System | CHL | Class II | Clinical Chemistry |
| 2022-10-18 | K203549 | Nova Primary Glucose Analyzer System | CGA | Class II | Clinical Chemistry |
| 2020-04-14 | K200403 | Stat Profile Prime Plus Analyzer System | JGS | Class II | Clinical Chemistry |
| 2020-04-06 | K200204 | Stat Profile Prime Plus Analyzer System | GGZ | Class II | Hematology |
| 2020-03-13 | K200349 | Stat Profile Prime Plus Analyzer System | CGA | Class II | Clinical Chemistry |
| 2020-01-24 | K193246 | Stat Profile Prime Plus Analyzer System | CHL | Class II | Clinical Chemistry |