Reported Oct 23, 2019 · Terminated
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for…
Vital Scientific N.V.
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: Vital Scientific N.V. · 24, Kanaalweg · Dieren, N/A · N/A
Is this the product you have?
- Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418
- Product Usage:clinical chemistry system intended for use in clinical laboratories
- Lot codes and dates
- serial numbers
11-960911-969011-969411-969512-961812-9620
- serial numbers
- Amount recalled
- 6 instruments
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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