CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
REF: 666289 , BD Facs, 7-Color Setup Beads, 25 Runs, CE recalled
Becton, Dickinson and Company, BD Bio Sciences is recalling REF: 666289 , BD Facs, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in, distributed in 37 states. The recall was initiated on 3 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2079-2025
- FDA event ID
- 96922
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2025
- FDA classified
- 3 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2025 | Recall initiated by company | |
| 3 Jul 2025 | Classified by FDA | +30 days |
| 9 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Where it was distributed
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:
ArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaNorth Carolina
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 85637 & 85638/ UDI: 382906662897
Where was it sold?
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:
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96922| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | REF: 335775 , BD Facs, 7-Color Setup Beads, 25 setups per kit, Rx recalled | Becton, Dickinson and Company, BD Bio Sciences | Other | 37 states |
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|---|---|---|---|---|---|
| Device | CLASS II | BD Trucount Controls, 30 Test recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Bio Sciences | Processing Deviation | Nationwide |
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| Device | CLASS II | REF: 335775 , BD Facs, 7-Color Setup Beads, 25 setups per kit, Rx recalled | Becton, Dickinson and Company, BD Bio Sciences | Other | 37 states |
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