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FDA-Device2026-04-22Class IIPROCESSING DEFECT

Therakos Cellex Photopheresis System recalled for centrifuge bowl installation difficulty

Theranos
OTHERNationwide distribution

Stop using affected Cellex Photopheresis kits

The centrifuge bowl on certain Cellex Photopheresis System kits may be difficult to install properly onto its holder. If not installed correctly, the bowl can break during use, which could delay patient treatment and cause blood loss.

  • Stop using kits with lot numbers N301, N339–N347
  • Contact Therakos for instructions on verifying proper bowl installation or obtaining a replacement
  • Review the installation procedure carefully before any future use of other kits
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
5826
Manufactured in
Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Road North, N/A, Blanchardstown, N/A, Ireland
Products
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS 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. Component: Not Applicable

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1822-2026

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