Stat Profile Prime® Plus Analyzer
Brand(s)
Last updated
Summary
Product
Stat Profile Prime® Plus Analyzer
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number/ |
|---|---|---|
| Stat Profile Prime® Plus Analyzer | PP1218410C PP14210410C PP1918190C PP1C18130C PP12210030C PP12210080C PP1420880C PP15230050C PP16220090C PP1918340C PP1419210C PP14230260C PP12230670C PP18220170C PP18220090C PP1219230C PP1420180C PP1319060C PP15230030C PP18220130C PP18220180C PP19181902 PP1918321C PP1B18340C | 57400 59508 |
| Stat Profile Prime® Plus POC Analyzer | PP31220460C PP33230230C | 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Chemistry
Companies
Nova Biomedical Corporation
200 Prospect St., Waltham, Massachusetts, United States, 02454
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74618
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