03

Oct

2024

FDA Recall: Software Issue May Cause Inaccuracies in Specimen Dispensed

0

Company: Becton, Dickinson and Company, BD Bio Sciences
Date of Enforcement Report: 10/03/2024
Class II

PRODUCT

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.

Recall Number:

Z-0009-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Becton, Dickinson and Company, BD Bio Sciences

VOLUME OF PRODUCT IN COMMERCE:

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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