Nova Biomedical Corporation Recall: Nova Stat Profile Prime Plus POC Analyzer (CE)-Intende
Nova Biomedical Corporation Recall: Nova Stat Profile Prime Plus POC Analyzer (CE)-Intende is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Nova Biomedical Corporation; Product: Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or p
| Recalling firm | Nova Biomedical Corporation |
|---|---|
| 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, 63368 |
| 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 II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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 |
| Recall initiated | 20230918 |
| Recall number | Z-0208-2024 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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