FDA Device recall Z-0207-2024
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57…
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57… 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-0207-2024 |
| 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 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
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: (1) 00385480574006 (2) 00385480595087 All software versions (V1.17.1123.0 and V3.2.1123.0) |
|---|
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-0207-2024%22
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