Drug recall

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

FDA recall event 96922 · Class II · Becton, Dickinson and Company, BD Bio Sciences

Key facts

Event ID 96922
Recall numbers Z-2078-2025, Z-2079-2025
Recalling firm Becton, Dickinson and Company, BD Bio Sciences
Product type Devices
Products REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation., REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
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.
Initiation date Jun 3, 2025
Report date Jul 9, 2025
City Milpitas
State CA
Country United States
FEI number 3027394506

At a glance

  • 1–9 Products in this recall
  • None FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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