Z-2585-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- July 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product Description
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Reason for Recall
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.
Distribution Pattern
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
Code Information
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,