Recall Z-2079-2025— Becton, Dickinson and Company, BD Bio Sciences

Name: FDA recall Z-2079-2025
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: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, 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: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, 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.