FDA Device recall Z-0208-2024
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.…
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.… by Nova Biomedical, citing 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 fi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0208-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-18 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nova Biomedical |
| Distribution | US |
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
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2024%22
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