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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall identifies a potential risk of erroneous measurement results that could lead to patient harm through misdiagnosis or incorrect treatment. No confirmed patient harm is documented in the source material. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity rating.
Plain-English summary
The Nova Biomedical Corporation is recalling the Stat Profile Prime Plus POC (point-of-care) analyzer due to a potential risk of erroneous creatinine patient results. The issue occurs within the first 2-4 hours after installation of a new BUN/Creatinine sensor cartridge. During this critical startup period, the analyzer may report inaccurate results that may not be identified by traditional quality control practices.
The affected products include the Nova Stat Profile Prime Plus POC Analyzer (PN 63368) and the Nova Stat Profile Prime Plus POC Analyzer Remanufactured (PN 63369). A total of 161 units have been identified. The devices have been distributed nationwide and internationally, including to Canada, the United Kingdom, Australia, and numerous other countries.
Healthcare facilities using these devices should be aware of the 2-4 hour startup window following each sensor cartridge installation. Results obtained during this initial period should be verified through alternative testing methods or by running additional quality control checks before patient reporting. Facilities should also update staff to exercise increased caution during cartridge changes to minimize the risk of erroneous results affecting patient care.
The recalled product
- 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…
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nova Biomedical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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