BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), RE

FDA device recall Z-0009-2025 · posted 2024-10-03 · Open, Classified

Recall details

Recalling firm

Becton, Dickinson and Company, BD Bio Sciences

Reason for recall

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

Action taken

On 8/12/2024, correction notices were sent to customers who were informed of the following; 1) Cease use of the sample preparation system with software version 1.4.1. until the Multidispense feature has been disabled. Patient samples can be prepared using single dispense on the sample preparation system or manually. 2) It is recommended that laboratories upgrade affected sample preparation systems to version 1.4.2 to correct the issue as soon as it is available. 3) Ensure the contents of this notification are read and understood by those within your organization. 4) Complete and return the response form via email to BDRC38@bd.com If you require further assistance, contact: 1-844-823-5433, Mon-Fri 8:00am and 5:00pm CT or email productcomplaints@bd.com. Recall related questions can be emailed to BDRC38@bd.com

Root cause

Software change control

Status

Open, Classified

Product code

PER

Quantity affected

130

Distribution

US: NJ, UT, WI, TX, ID, AK, MN, MA, MD, TN, MI, CA, VA OUS: Ireland, Austria, Italy, Germany, Belgium, Finland, Canada, France, Spain, New Zealand, United Kingdom, Japan, Australia, Norway, Singapore,

Date initiated

2024-08-12

Date posted

2024-10-03

Location

Milpitas, CA