Lower riskMedical device recall · FDA · Published September 18, 2023
Nova Stat Profile Prime Plus POC Analyzer: Erroneous Creatinine Results Risk
Nova Biomedical recalls its Stat Profile Prime Plus POC Analyzer due to potential erroneous creatinine results in the first 2-4 hours after new sensor cartridge installation. Affected units have specific model numbers and software versions.
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.
Take action
Contact the company
📍Recalling firmNova Biomedical Corporation200 Prospect St · Waltham, MA 02453-3407
✎ GovInfoNow plain-language explainer
Nova Biomedical is recalling its Stat Profile Prime Plus POC Analyzer because it may report incorrect creatinine results during the first 2-4 hours after installing a new BUN/Creatinine Sensor Cartridge. This could lead to inaccurate blood test results if the device is used without proper quality checks. Read more at govinfonow.com/recall/57306-nova-stat-profile-prime-plus-poc-analyzer-erroneous-creatinine-results.
“Nova Stat Profile Prime Plus POC Analyzer: Erroneous Creatinine Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57306-nova-stat-profile-prime-plus-poc-analyzer-erroneous-creatinine-results. Based on FDA recall #Z-0208-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2024%22&limit=1).
Nova Biomedical Corporation voluntarily recalled the Nova Stat Profile Prime Plus POC Analyzer (CE) on Sept. 18, 2023, according to the FDA. The device poses a risk of reporting erroneous creatinine patient results during initial start-up of new BUN/Creatinine Sensor Cartridges.
How to tell if you have it
PN 63368 Stat Profile Prime Plus POC Analyzer
PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured
P/N: 57400
The hazard
The recall addresses a potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. This error may occur within the first 2-4 hours after cartridge installation and might not be identified by traditional Quality Control practices.
Context
GovInfoNow's records show Nova Biomedical Corporation has 3 other recalls on record since 2017-06-19. Other recent recalls of similar products include Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18) and GEM Premier 5000 PAK recall (2026-01-20).
How to tell if you have this one
Check for model numbers 63368 or 63369 (remanufactured) with software versions W1.17.1123.0 or W3.2.1123.0 (international) or V1.50.1123.0 (China).
Brand
Nova Biomedical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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 Malaysia Malta Mexico Moldova Morocco Nepal Netherlands New Zealand Oman Pakistan Palestine Paraguay Paraquay Peru Philippines Poland Puerto Rico Qatar Republic of Panama Romania Russia Rwanda Saudi Arabia Serbia Slovenia South Africa South Korea Spain Sri Lanka Sudan Sweden Switzerland Syria Thailand Trinidad Trinidad,W.I. Tunisia UK Ukraine United Arab Emerites Uruguay Vietnam
Recall number
Product, codes & lots
Quantity
Z-0207-2024
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; UDI-DI: (1) 00385480574006 (2) 00385480595087 All software versions (V1.17.1123.0 and V3.2.1123.0)
1779 units: 438 US; 1341 OUS
Z-0208-2024
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; UDI-DI: N/A All software versions: International Except China: W1.17.1123.0 and W3.2.1123.0 V1.50.1123.0 China: V1.50.1123.0
161 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on your device (63368 or 63369) and software version.
Verify Software Version
Ensure your device has the specific software versions listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0208-2024 (September 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0208-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.