Reported Apr 22, 2026 · Ongoing
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software…
Therakos Development Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: THERAKOS DEVELOPMENT LIMITED · Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Road North · Blanchardstown, N/A · N/A
Is this the product you have?
- Brand NameCellex
- Photopheresis System Product NameCELLEX
- Photopheresis Kit Model/Catalog NumberCLXUSA
- Software VersionNot
- Applicable Product DescriptionTHERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream
- ComponentNot Applicable
- Lot codes and dates
- Model/Catalog NumberCLXUSA
- UDI-DI20705030200003
- Lot Numbers
N301N339N340N341N342N343N344N345N346N347P302P303P304P305P306P307P308P309P310P311P312P313P314P319P320
- Amount recalled
- 11,499 units
Where it was sold
- Nationwide
Why it was recalled
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
This product could cause temporary or reversible health problems — stop using it.
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