The Recall Desk

FDA (Devices) recall action 93095

Nova Biomedical Corporation recalled 2 products on 2023-11-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-11-08
Critical
0
Units
161

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2023-11-08

    Blood Gas Analyzer Software Issue Causes Erroneous Creatinine Results During Startup

    Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.

    Product
    Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-11-08

    POC Analyzer Risk of Erroneous Creatinine Results During Cartridge Startup

    Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.

    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 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 633
    Category
    Distribution
    0 states