Automated Colony Counter
Microbiology · 21 CFR 866.2170
Recent MDR events
4 adverse event reports on file
- BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTIONApr 14, 2026MalfunctionBd Kiestra Lab Automation3010141591-2026-00003
- UNIFUSORSep 16, 2010MalfunctionCas Medical Systems, Inc. (statcorp)2244861-2010-00001
- ANOXOMAT MARK IIMay 29, 2007MalfunctionSpiral Biotech, Inc.867575
- UNK TONSIL SNARE WIREApr 23, 2004OtherCardinal Health1423507-2004-00033
Event type breakdown
Recalls
2 recall events for this product code
- Copan WASPOpen, ClassifiedMay 21, 2025
PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
Z-1812-2025 · View FDA record ↗ - Becton Dickinson & Co.Open, ClassifiedAug 14, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
Z-2585-2024 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
1 clearances for this product code