Official recall record
Stat Profile Prime® Plus Analyzer
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-11-20
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Nova Biomedical became aware of a 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. Recall start date: September 13, 2023
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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