FDAJanuary 10, 2012device
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
What to do
FDA enforcement status: Terminated
Brands named
vital scientific n vvitalvital scientific
UPCs
0366154060039503661540600401
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDALUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.52026-03-30
- FDABoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.2026-03-19
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