Nova Stat Profile Prime Plus POC Analyzer recall
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN…
Why was Nova Stat Profile Prime Plus POC Analyzer 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: N/A All software versions: International Except China: W1.17.1123.0 and W3.2.1123.0 V1.50.1123.0 China: V1.50.1123.0
- Product
- Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN…
- Recalling firm
- Nova Biomedical Corporation
- Quantity
- 161 units
- Distribution
- Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Republic Ecuador Egypt El Salvador Finland France Germany Greece Guatemala India Indonesia Ireland Israel Italy Japan JORDAN Kazakhstan Kenya Kurdistan, Iraq Kuwait Malaysia Malta Mexico Moldova Morocco Nepal Netherlands New Zealand Oman Pakistan Palestine Paraguay Paraquay Peru Philippines Poland Puerto Rico Qatar Republic of Panama Romania Russia Rwanda Saudi Arabia Serbia Slovenia South Africa South Korea Spain Sri Lanka Sudan Sweden Switzerland Syria Thailand Trinidad Trinidad,W.I. Tunisia UK Ukraine United Arab Emerites Uruguay Vietnam
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)