Selectra ProS Analyzer recall
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Why was Selectra ProS Analyzer recalled?
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.
- Product
- Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Recalling firm
- Vital Scientific N.V.
- Quantity
- 6 instruments
- Distribution
- US Nationwide in the states of NY, and UT
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)