BD Kiestra Urine Culture Application Powered by BD Synapsys… — Class II medical device recall Z-2585-2024
Ongoing recall by Becton Dickinson & Co., reported 2024-08-21, distributed in CO, CT, IA, IL, KY, MD, MI, MN…. There is a potential risk that the image colony count does not adequately reflect the actual plate colony coun
| Recall number | Z-2585-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-07-09 |
| Classified | 2024-08-13 |
| Reported by FDA | 2024-08-21 |
| Distributed | CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX, WA |
| Quantity | 23 units |
| UPC / GTIN / UDI-DI | 00382904449001 |
| Serial numbers | IA00005, IA00007, IA00011, IA00012, IA00014, IA00025, IA00026, IA00027, IA00034, IA00041, IA00050, IA00053, IA00054, IA00055, IA00071, IA00073, IA00081, IA00084, IA00085, IA00086, IA00088, IA00108, SL01023 |
| Model numbers | 00382904449001, 444900 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2585-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.