THERAKOS recalls CELLEX Photopheresis Kit model CLXUSA due to risk of centrifuge bowl dislodging during use, causing blood loss and treatment delays. Affected patients should contact for remedy.
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.
THERAKOS is recalling its CELLEX Photopheresis Kit model CLXUSA because improper installation of the centrifuge bowl can cause it to dislodge, leading to blood loss and delayed treatment. This risk affects patients using the kit for photopheresis therapy.
The centrifuge bowl may become loose if not installed correctly. If it dislodges during the treatment process, it can cause blood loss and delay patient treatment.
Patients using the THERAKOS CELLEX Photopheresis Kit model CLXUSA for photopheresis therapy are most at risk. The recall applies to those who have the specific model number CLXUSA.
Check for the model number CLXUSA on the kit. The recall covers specific lot numbers and production batches listed in the product description.
Ensure the centrifuge bowl is securely attached to the holder before each use.
The recall is due to increased difficulty in installing the centrifuge bowl, which may cause it to dislodge during treatment, leading to blood loss and treatment delays.
The affected model is CLXUSA, with specific lot numbers N301 through N347 and P302 through P314, P319 through P320.
No, but you should check the installation before each use to prevent dislodging the bowl.
We’ve drafted a message you can send THERAKOS to request your refund or repair — edit it as you like.
Subject: Recall Z-1822-2026 — THERAKOS THERAKOS Hello, I own a THERAKOS that is covered by recall Z-1822-2026 from THERAKOS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
