FDA Enforcement
Class II
Ongoing
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Recall: Z-2585-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2585-2024
- Event ID
- 94965
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- July 9, 2024
- Classification Date
- August 13, 2024
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212, United States
Description
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Reason
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.
Code Info
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,
Distribution
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
Quantity
23 units