CELLEX CLXSP-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00705030000005), received between Feb 10, 2025 and Sep 29, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).

8 other recalls cover devices cleared under the same FDA submission (P860003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939006 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak

  The customer contacted Therakos to report they experienced a Photoactivation Module Leak with their CELLEX Photopheresis Kit ("Kit") during an Extracorporeal Photopheresis (ECP) treatment. The customer reported that they received an Alarm # 8: Blood Leak? (Photoactivation Chamber) at the end of photoactivation. The customer confirmed a crack within the photoactivation module, causing a leak. The ECP treatment was aborted and the residual blood within the Kit was not returned to the patient. The customer reported the patient was in stable condition. No product was returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474027 ↗
• MalfunctionJun 23, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL BREAK/LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE AT THE BEGINNING OF THE TREATMENT. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25603165 ↗
• MalfunctionJun 18, 2026Break; Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER STATED THE DRIVE TUBE HAD A CIRCULAR NOTCH NEXT TO THE BEARING LOCATED NEAR THE CENTRIFUGE BOWL AND PROVIDED PHOTOS TO ILLUSTRATE.THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545724 ↗
• MalfunctionJun 11, 2026Break

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A DRIVE TUBE LEAK/BREAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER DENIES ANY DIFFICULTY WITH THE CENTRIFUGE INSTALLATION. THE CUSTOMER HAS NOT RETURNED ANY PRODUCT OR PRODUCT COMPONENTS, NOR ANY PHOTOGRAPHS, FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470843 ↗
• MalfunctionMay 1, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 470 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058217 ↗
• MalfunctionMay 1, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM # 16: COLLECT PRESSURE AND ALARM # 17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 461 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056875 ↗
• MalfunctionMay 1, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 499 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056306 ↗
• MalfunctionMay 1, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 576 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THEY HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056011 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY 100 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER REPORTED THAT THE BOWL HAD BEEN INSTALLED PROPERLY WITHOUT ISSUES AND THAT NO OTHER ALARMS HAD OCCURRED. THE TREATMENT WAS ABORTED AND STARTED AGAIN WITH ANOTHER DEVICE. THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903575 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A BAG LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE BAG LEAK OCCURRED DURING THE PROCEDURE. THE ECP TREATMENT WAS COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER DISCARDED THE KIT. THE CUSTOMER RETURNED A PHOTOGRAPH FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435830 ↗
• MalfunctionJan 16, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK FROM THE PRESSURE DOME DURING TREATMENT, AFTER 250 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURNED WAS REQUESTED; HOWEVER IT WAS DISCARDED. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099540 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK FROM THE PRESSURE DOME AT THE BEGINNING OF TREATMENT. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURNED WAS REQUESTED; HOWEVER, IT WAS DECLINED. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060531 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY OBSERVED A LEAK AT THE PRESSURE DOME AFTER 200MLS OF WHOLE BLOOD WAS PROCESSED. THE TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER DISCARDED THE KIT. THE CUSTOMER WILL NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879337 ↗
• MalfunctionNov 21, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT BLOOD CLOTTING IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #17: RETURN PRESSURE ALARM OCCURRED, AND THEY OBSERVED BLOOD CLOTS IN THE RETURN LINE AFTER 949MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER WILL NOT RETURN THE KIT. THE CUSTOMER RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622409 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A BAG LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BAG LEAK DURING THE PROCEDURE AFTER 1500ML OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL NOT RETURN THE PRODUCT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468345 ↗
• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE DRIVE TUBE BROKE DURING TREATMENT. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED A PHOTOGRAPH FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678987 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY OBSERVED A LEAK NEXT TO THE SYSTEM PRESSURE DOME AFTER 60ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667678 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #7: BLOOD LEAK? (CENT CHAMBER) ALARM AND THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER WILL NOT RETURN THE KIT. THE CUSTOMER WILL NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468490 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A LEAK COMING FROM THE COLLECT PRESSURE DOME AT THE START OF TREATMENT, AFTER 26 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE COMPLAINT KIT WAS REQUESTED; HOWEVER, IT HAD BEEN DISCARDED. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382159 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PHOTOACTIVATION MODULE LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT DURING THE TREATMENT, A LEAK WAS OBSERVED IN THE PHOTOACTIVATION MODULE AFTER 1507 OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND NO BLOOD FROM THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER DISCARDED THE KIT. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134287 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE RETURN PRESSURE DOME LEAKED DURING TREATMENT AFTER 100ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED PHOTOGRAPHS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395858 ↗
• MalfunctionFeb 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE DRIVE TUBE BROKE DURING TREATMENT AFTER 1425ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED THE KIT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21348618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860003. One submission often covers many models, so check the product and lot details in each record.

• Z-1822-2026 · May 16, 2025 · Open, Classified
  Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopher
• Z-0567-2022 · Dec 10, 2021 · Open, Classified
  THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
• Z-0212-2022 · Oct 4, 2021 · Open, Classified
  THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
• Z-1322-2016 · Dec 21, 2015 · Terminated
  The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood i
• Z-0595-2012 · Sep 1, 2011 · Terminated
  Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive dr
• Z-2067-2011 · Feb 1, 2011 · Terminated
  Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
• Z-2839-2011 · Dec 2, 2010 · Terminated
  Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
• Z-1504-06 · Jul 18, 2006 · Terminated
  Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)