Becton, Dickinson and Company, BD Bio Sciences: Device Recall

Recall Details

Recall Number

Z-0009-2025

Classification

Class II

Product Type

Device

Recalling Firm

Becton, Dickinson and Company, BD Bio Sciences

Status

Ongoing

Date Initiated

08/12/2024

Location

Milpitas, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

130

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.

Product Description

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

Distribution Pattern

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, Sweden, Turkey, Brazil, Colombia, Netherlands, United Arab Emirates, Saudi Arabia, Mexico, Switzerland, Costa Rica, China, Azerbaijan, Algeria, Jordan, India

Other Recalls by Becton, Dickinson and Company, BD Bio Sciences

• Class II: Risk 07/08/2025
  Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
• Class II: Risk 07/08/2025
  Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
• Class II: Risk 06/03/2025
  Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
• Class II: Risk 06/03/2025
  Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
• Class II: Risk 11/01/2024
  On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

View all recalls by Becton, Dickinson and Company, BD Bio Sciences →