Z-2585-2024Class II

BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900

Name: Z-2585-2024 BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900
Creator: Becton Dickinson & Co.
Published: 2024-07-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-07-09 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900 on 2024-07-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2585-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-08-14
Recalling firm: Becton Dickinson & Co
Product: BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Product code: KZB Automated Colony Counter
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.
FDA 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: [email protected] or Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted, Mon Fri 8:00am and 5:00pm CT or Email: [email protected].
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2585-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2585-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-13

Product code KZB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)