Lower risk Medical device recall · FDA · Published July 9, 2024

BD Kiestra Urine Culture Device May Cause Inaccurate Patient Counts

Becton Dickinson recalls BD Kiestra Urine Culture Application with potential for inaccurate colony counts, risking patient diagnosis errors. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2585-2024Medical device Becton Dickinson ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling its BD Kiestra Urine Culture Application device because it may produce inaccurate colony counts, which could lead to wrong patient diagnoses and treatments. This recall affects specific units with known serial numbers. Read more at govinfonow.com/recall/54689-bd-kiestra-urine-culture-device-may-cause-inaccurate-patient-counts.

Source Summary by GovInfoNow · govinfonow.com/recall/54689-bd-kiestra-urine-culture-device-may-cause-inaccurate-patient-counts · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2585-2024

Cite this page

“BD Kiestra Urine Culture Device May Cause Inaccurate Patient Counts.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54689-bd-kiestra-urine-culture-device-may-cause-inaccurate-patient-counts. Based on FDA recall #Z-2585-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2585-2024%22&limit=1).

Becton Dickinson & Co. voluntarily recalled the BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution, catalog number 444900, according to the FDA on July 9, 2024. The device may produce inaccurate colony counts that could impact patient diagnosis and care.

How to tell if you have it

Brand: Becton Dickinson
Product: BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution
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: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA

The hazard

The FDA stated there is a potential risk that the image colony count does not adequately reflect the actual plate colony count. This may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include BD GasPak EZ Campy Pouch System Recall (April 7, 2026), BD Kiestra Isolate Suspension Cuvette Array Recall (Oct. 23, 2025), and Becton Dickinson Veritor Connect Software Recall (Sept. 23, 2025). Other recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check for serial numbers listed in the recall: IA00084, IA00054, IA00055, IA00088, IA00041, IA00071, IA00085, IA00007, IA00014, IA00005, IA00053, IA00073, IA00081, IA00011, IA00012, IA00027, SL01023, IA00026, IA00050, IA00034, IA00025, IA00086, IA00108.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for the specific serial numbers listed in the recall to determine if your device is affected.

Where it went and when

Where it was distributed

Distributed in 17 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Connecticut, Illinois, Iowa, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Washington.

Recall timeline

FDA published this recall 43 days after the firm started it.

Jul 9, 2024Firm started the recall
Aug 13, 2024FDA classified it Class II
Aug 21, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/54689-bd-kiestra-urine-culture-device-may-cause-inaccurate-patient-counts">BD Kiestra Urine Culture Device May Cause Inaccurate Patient Counts (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2585-2024 (July 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2585-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.