—#208984

Product

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

FDA product code: KZB — Automated Colony Counter
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.

Timeline

Recall initiated: 2024-07-09
Posted by FDA: 2024-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.