FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
- Recall number
- Z-2585-2024
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
- Status
- Open, Classified
- Initiated
- 2024-07-09
- Posted
- 2024-08-14
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- On July 9, 2024, "URGENT: Medical Device Product Correction" letters were sent to customers. Actions for Clinical Users: Users must review the plate images against the actual agar plate to verify the automated colony count results. Actions to be taken by customer: 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification per FDA requirements. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 Contact Information: If you require further assistance, please contact: BDRC42@bd.com or Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted, Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com.
- Quantity
- 23 units
- Distribution
- US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KZB
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28