Nova Biomedical Corporation recalls StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for…
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 management system (DMS) at healthcare sites using WiFi if a user…
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Nova Biomedical
- Product
- StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for…
- Classification
- Class I
- Units
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Nova Biomedical recalls
- 2026-09-23
USNova Biomedical Corporation recalls StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID)…
FDA · DeviceNova Biomedical CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →- 2025-01-01
- US
Nova Biomedical Corporation recalls StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
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 data management system (DMS) at healthcare sites using…
FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice → - 2023-11-08
- US
Nova Biomedical Corporation recalls Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and…
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge…
FDA · DeviceNova Biomedical CorporationNationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-01
- US
MEDLINE INDUSTRIES, LP - Northfield recalls KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and…
- US
Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from…
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
- US
Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- US
Nova Biomedical Corporation recalls StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
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 data management system (DMS) at healthcare sites using…
FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice → - US
MXBBB recalls UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product…
- US
RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.