Nova Biomedical Stat Profile Prime Analyzer Software Issue May Overwrite Patient Results
Nova Biomedical recalls Stat Profile Prime analyzers with specific model numbers due to software that may overwrite patient results before they are released. Affected units include PN 52855, 52856, 528:53655, 53656, 53657, 52857. No remedy is specified in the recall notice.
Lower-risk recall
Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.
Contact the company
What happened, in plain English
Nova Biomedical is recalling several models of Stat Profile Prime analyzers because software issues could cause patient results to be overwritten with quality control data before the operator releases them. This means results might be incorrect, potentially affecting medical decisions. Read more at govinfonow.com/recall/73829-nova-biomedical-stat-profile-prime-analyzer-software-issue-may-overwrite.
Source Summary by GovInfoNow · govinfonow.com/recall/73829-nova-biomedical-stat-profile-prime-analyzer-software-issue-may-overwrite · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2732-2017
Cite this page
“Nova Biomedical Stat Profile Prime Analyzer Software Issue May Overwrite Patient Results.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73829-nova-biomedical-stat-profile-prime-analyzer-software-issue-may-overwrite. Based on FDA recall #Z-2732-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2732-2017%22&limit=1).
Why it’s dangerous
The software schedules quality control (A-QC) analyses that could run before the operator releases a patient's results. This might overwrite the patient's results with the A-QC data, leading to incorrect results being used for medical decisions.
Who’s affected
Healthcare professionals using the Stat Profile Prime analyzers with model numbers PN 52855 through PN 52857 and PN 53655 through PN 53657 are most at risk. Patients using these devices for blood gas and electrolyte testing may also be affected.
How to tell if you have this one
Check the product model number on the device or its packaging. Affected models include PN 52855, 52856, 52857, 53655, 53656, 53657. These analyzers were sold with specific software versions for blood gas and electrolyte testing.
- Brand
Nova Biomedical- Category
Medical device
What to do — step by step
Check Model Number
Look for the product model number on the device or its packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana…” 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 terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2732-2017 (June 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2732-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.