Recall Z-2078-2025— Becton, Dickinson and Company, BD Bio Sciences

Name: FDA recall Z-2078-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-03

Class II · Ongoing

Class II FDA medical device recall by Becton, Dickinson and Company, BD Bio Sciences, initiated 2025-06-03. It names one FDA 510(k) clearance: K040026. Product: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.. Reason: 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..

Recalling firm: Becton, Dickinson and Company, BD Bio Sciences
Classification: Class II
Status: Ongoing
Initiated: 2025-06-03
Firm location: Milpitas, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K040026 — BD FACS 7-COLOR SETUP BEADSBecton Dickinson Immunocytometry Systems·cleared 2004-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.