Reported Jul 19, 2017 · Terminated
Nova Biomedical Stat Profile Prime Analyzer as follows
Nova Biomedical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nova Biomedical Corporation · 200 Prospect St · Waltham, MA · 02453-3457
Is this the product you have?
Nova Biomedical Stat Profile Prime Analyzer as follows
6 of 6 products
| Model / number | Product as published |
|---|---|
52855 | Stat Profile Prime ABG Analyzer |
53655 | Stat Profile Prime ABG Analyzer with Scanner |
52856 | Stat Profile Prime CCS Analyzer |
53656 | Stat Profile Prime CCS Analyzer with Scanner |
53657 | Stat Profile Prime CCS Comp Analyzer with Scanner |
52857 | Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer |
- Lot codes and dates
- All current software versions
- Amount recalled
- 179 units (US) and 904 (OUS) Total 1083
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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