Z-2078-2025Class II

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

Name: Z-2078-2025 REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for...
Creator: Becton, Dickinson and Company, BD Bio Sciences
Published: 2025-06-03
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2025-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Bio Sciences began a recall of REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation on 2025-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2078-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-03
Posted: 2025-07-03
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 3, 2025, Becton, Dickinson issued a "Urgent: Medical Device Recall Correction" Notification to affected customers via mail and E-Mail. BD asked consignees to take the following action: 1: Immediately inspect your inventory for the specific catalog and lot numbers listed. It is recommended that the clinical laboratory staff review and segregate the affected lots. 2. Remove and discard prior affected label insert with incorrect spectral overlap factor values included on kit box prior to use. 3. The wrong SOF (Spectral Over Factors) values can be corrected by entering the right SOF values provided in Table 1. 4. Ensure the right SOF values are entered in the flow cytometry instrument prior to sample acquisition. 5. Customers who have not used the affected product may proceed to enter the SOF values. 6. If the affected products have been fully or partially used and subjects' samples have been processed and acquired on an instrument with the incorrect SOF values, please review the results. 7. If the subject sample(s) is not available anymore, this may require the subject to return to collect an additional sample for testing purposes. 8. Ensure the contents of this Product Recall Notification are read and understood. 9. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness.
Quantity in commerce: 590 units
Distribution: US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan OUS:
Product codes and lots: Lot # 85612 & 85613/ UDI: 382903357758

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2078-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2078-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2079-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03

Product code GKZ

K040026Class IIBd Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems / cleared 2004-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)