Recall archive / FDA device enforcement
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900; — FDA record Z-2585-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 23 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2585-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 21, 2024
- Recall initiation date
- Jul 9, 2024
- Center classification date
- Aug 13, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.