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 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nova Biomedical Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0208-2024
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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 navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.