Nova Stat Profile Prime Plus POC Analyzer — Class II medical device recall Z-0208-2024
Ongoing recall by Nova Biomedical Corporation, reported 2023-11-08, distributed nationwide. Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new
| Recall number | Z-0208-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Biomedical Corporation, Waltham, MA, United States |
| Recall initiated | 2023-09-18 |
| Classified | 2023-11-01 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HR, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LK, MA, MT, MX, MY, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PY, QA, RO, RS, RU, SA, SE, SI, SV, TH, TN, TT, UA, UY, VN, ZA |
| Quantity | 161 units |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.