Nova Biomedical Corporation 2023-11-08 Health serious FDA
Health · FDA · Recall #FDA-Z-0208-2024
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in… Recall
Issued November 8, 2023 · Nova Biomedical Corporation
In November 2023, Nova Biomedical Corporation recalled the Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 installation that may not be identified by traditional Quality Control practices.
What you should do
- 1 Stop using Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Nova Biomedical Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Nova Biomedical Corporation
- Category
- Health
- Recall date
- November 8, 2023
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Repub
- Recall number
- FDA-Z-0208-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Nova Biomedical Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.