FDAFDA · Food and drugs·Recall number Z-2585-2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Published August 21, 2024 · Recall initiated: July 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
- Lot
- Catalog (Ref): 444900; UDI-DI: 00382904449001; Serial Numbers: IA00084, IA00054, IA00055, IA00088, IA00041, IA00071, IA00085, IA00007, IA00014, IA00005, IA00053, IA00073, IA00081, IA00011, IA00012, IA00027, SL01023, IA00026, IA00050, IA00034, IA00025, IA00086, IA00108,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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