CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 recalled
Agilent Technologies Denmark ApS is recalling FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended, distributed nationwide in the US. The recall was initiated on 11 Aug 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-2564-2025
- FDA event ID
- 97421
- Recalling firm
- Agilent Technologies Denmark ApS, Glostrup, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Aug 2025
- FDA classified
- 15 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 11 Aug 2025 | Recall initiated by company | |
| 15 Sep 2025 | Classified by FDA | +35 days |
| 24 Sep 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is the potential for weak staining which may result in false negative CD20 identification.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
Where it was distributed
US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Nationwide AlabamaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMississippiNorth CarolinaNorth DakotaNew JerseyNevadaNew York
Questions about this recall
Is FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended recalled?
Yes. Agilent Technologies Denmark ApS recalled FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended on 11 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2564-2025.
Why was it recalled?
Their is the potential for weak staining which may result in false negative CD20 identification.
Which lots are affected?
Lot numbers: 41781549, 41762487, 41651581 GTIN:
Where was it sold?
US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Agilent Technologies Denmark ApS
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 recalled | Agilent Technologies Denmark ApS | Device Malfunction | Nationwide |
| Device | CLASS II | FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 recalled | Agilent Technologies Denmark ApS | Device Malfunction | Nationwide |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |