Stat Profile Prime® Plus Analyzer
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number/ |
|---|---|---|
Stat Profile Prime® Plus Analyzer |
PP1218410C |
57400 |
Stat Profile Prime® Plus POC Analyzer |
PP31220460C |
63368 |
Stat Profile Prime® Plus POC Analyzer (Remanufactured) |
Not applicable. |
63369 |
Issue
Nova Biomedical became aware of a 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.
Recall start date: September 13, 2023
Additional information
Details
Nova Biomedical Corporation
200 Prospect St., Waltham, Massachusetts, United States, 02454
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