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U.S. Department of Health and Human Services

Class 2 Device Recall BD Kiestra" Urine Culture Application Powered by BD Synapsys" Informatics Solution

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 Class 2 Device Recall BD Kiestra" Urine Culture Application Powered by BD Synapsys" Informatics Solutionsee related information
Date Initiated by FirmJuly 09, 2024
Date PostedAugust 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2585-2024
Recall Event ID 94965
Product Classification Automated colony counter - Product Code KZB
ProductBD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Code Information 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.
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactSarah Robles
304-839-4504
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce23 units
DistributionUS distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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