Recall Z-0207-2024 ยท JGS Electrode, Ion Specific, Sodium
Nova Biomedical Corporation
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
| Date | Nov 1, 2023 (initiated Sep 18, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | Nova Biomedical Customer Success Managers starting 9/18/23 contacted consignees directly via telephone, to review the bulletin with the consignee DRP, verify an email to send the bulletin to them, and then immediately forward the bulletin to them so they can share within their own healthcare facility. Letter states the reason for recall, health risk and action to take: Nova Biomedical recommends that your healthcare facility take one of the following risk mitigation steps after a BUN/Creatinine Sensor Cartridge replacement to reduce the possibility of this issue occurring in your facility un |
| Quantity | 1779 units: 438 US; 1341 OUS |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200403 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation, Apr 14, 2020 |