Class 2 Device Recall BD Kiestra

• Date Initiated by Firm: October 23, 2025
• Date Posted: November 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0484-2026
• Recall Event ID: 97817
• Product Classification: Device, general purpose, microbiology, diagnostic - Product Code LIB
• Product: BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100
• Code Information: Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: North American Regional Complaint Center; 844-823-5433
• Manufacturer Reason for Recall: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
• FDA Determined Cause: Under Investigation by firm
• Action: On October 23, 2025 URGENT: Medical Device Correction letters were sent to customers. Actions for Clinical Users: 1. Immediately inspect your inventory for the specific catalog and lot numbers listed to determine if the lot in your possession is impacted and immediately discard any remaining inventory of the affected product. 2. *Note: Lot LM245666 has undergone rework and will be used as replacement material for affected product. Reworked inventory from this lot can be identified using the indicators described in ATTACHMENT 1- How to Identify Affected vs Reworked Product. Action to be taken by customer 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter within your facility network 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 whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements.
• Quantity in Commerce: 29,760 units
• Distribution: Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
• Total Product Life Cycle: TPLC 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.