Class 2 Device Recall BD Trucount Controls

• Date Initiated by Firm: July 08, 2025
• Date Posted: August 01, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2237-2025
• Recall Event ID: 97141
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
• Code Information: Lot: 4285713/UDI: 00382906643438
• FEI Number: 3027394506
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Bio Sciences; 155 N Mccarthy Blvd; Milpitas CA 95035-5102
• For Additional Information Contact: BD Customer Service; 1844-823-5433
• Manufacturer Reason for Recall: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
• FDA Determined Cause: Labeling design
• Action: On July 8, 2025, BD Biosciences issued a "Urgent: Medical Device Recall Correction" via mail. BD ask consignees to take the following actions: 1. Ensure the contents of this product 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. It is recommended that this notice be posted where these products are stored. 4. 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 product, so that BD may acknowledge your receipt of this notification. 5. 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.
• Quantity in Commerce: 10 kits
• Distribution: Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.
• 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.