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…
Read the official notice →- Date
- 2023-11-08
- Country
- United States
- Brand
- Nova Biomedical
- Product
- Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and…
- Classification
- Class II
- Units
- Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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…
FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice → - 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 →
Other drugs & medical recalls in the United States
- 2023-11-08
- US
Cosmedent, Inc. recalls Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF…
Reports were received the elastomer cup material is crumbling.
FDA · DeviceCosmedent, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Maquet Cardiovascular, LLC recalls Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box…
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA · DeviceMaquet Cardiovascular, LLCUS (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.Official notice → - US
Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
- US
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical…
An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with…
- US
Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
FDA · DeviceSmiths Medical ASD Inc.Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH,…Official notice → - US
Coapt LLC recalls Coapt Dome Electrode, Gen2 system, cutaneous electrode
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
FDA · DeviceCoapt LLCWorldwide distribution - US Nationwide and the country of Sweden.Official notice →