Reported Nov 8, 2023 · Ongoing
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of…
Nova Biomedical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nova Biomedical Corporation · 200 Prospect St · Waltham, MA · 02453-3407
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
63368 | Stat Profile Prime Plus POC Analyzer (2) |
63369 | Stat Profile Prime Plus POC Analyzer, Remanufactured |
57400 | 63368 |
- Lot codes and dates
- UDI-DIN/A
- All software versionsInternational
- Except ChinaW1.17.1123.0 and W3.2.1123.0 V1.50.1123.0
- ChinaV1.50.1123.0
- Amount recalled
- 161 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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