Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,

FDA device recall Z-0208-2024 · posted 2023-11-01 · Open, Classified

Recall details

Recalling firm

Nova Biomedical Corporation

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.

Action taken

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 until your analyzers have received a software update. " If your analyzer tests patient samples frequently, initiate a manual analyzer calibration every 30 minutes within the first 2 hours, and then every hour for the next 2 hours after cartridge replacement. " If your analyzer tests patient samples infrequently, within the first 4 hours after cartridge replacement, initiate a manual analyzer calibration prior to performing a patient test. Until your Prime Plus analyzer(s) software is updated, if your healthcare facility experiences an erroneous creatinine result or adverse event after a new sensor cartridge installation, Nova encourages you to contact Nova Biomedical or your authorized distributor to properly document the incident. For adverse event(s), Nova encourages you to report the details using the MedWatch Online Voluntary Reporting Form, MedWatch Online Voluntary Reporting Form (fda.gov). INTERNAL HEALTHCARE FACILITY COMMUNICATION: This Field Correction Notice should be distributed to all those within your organization who need to be aware of this issue. Please notify other parties affiliated with your organization, which are affected by this notice. Please maintain awareness of this notice until the issue has been corrected with a scheduled software update. If you have any questions on the contents of this notice, would like to discuss other risk mitigation options

Root cause

Process design

Status

Open, Classified

Product code

JGS

Quantity affected

161 units

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

Date initiated

2023-09-18

Date posted

2023-11-01

Location

Waltham, MA

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