BD Trucount Controls, 30 Test - REF: 340335

FDA device recall Z-2238-2025 · posted 2025-08-01 · Open, Classified

Recall details

Recalling firm

Becton, Dickinson and Company, BD Bio Sciences

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.

Action taken

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.

Root cause

Labeling design

Status

Open, Classified

Product code

GKZ

Quantity affected

629 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, Philippi

Date initiated

2025-07-08

Date posted

2025-08-01

Location

Milpitas, CA