CliniMACS CD34 Reagent 70103Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04049934004827), received between Jan 14, 2016 and Dec 14, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER PERFORMED CD34+ ENRICHMENT ON THE CLINIMACS PLUS DEVICE S/N (B)(4) USING CLINIMACS LS TUBING SET L/N 7201200191, EXPIRY DATE 2023-05-01 AND CD34 REAGENT L/N 6210900028, EXPIRY DATE 2022-02-01. THE PROCESS RESULTED IN 16% OF CD34 POSITIVE CELL RECOVERY ACCORDING TO CUSTOMER QUALITY ASSESSMENT. AVERAGE YIELD REPORTED BY THIS CUSTOMER LIES BETWEEN 50 AND 85%. THE CUSTOMER USED PROGRAM CD34 SELECTION 2. THE CAPACITY OF THIS ENRICHMENT PROGRAM IN COMBINATION WITH THE CORRESPONDING TS (TS LS) IS 120X109 TOTAL NUCLEATED CELLS (WHITE BLOOD CELLS) AND 1200X106 (1,2 X109) LABELED CELLS. ACCORDING TO THE DATA PROVIDED BY THE CUSTOMER, THE LABELED SAMPLE CONTAINED 73.37X109 CELLS AND 0.3% LABELLED CELLS, THEREFORE IT WAS WITHIN THE SPECIFICATIONS OF THE PROCESS. ACCORDING TO THE DATA, PROVIDED BY THE CUSTOMER, THE LABELING INCUBATION TIME WAS 30' AT RT ON AN ORBITAL SHAKER AT 25 RPM, AND FOR THE WASH STEPS THE CELL SAMPLE WAS CENTRIFUGED FOR 15MINUTES AT 200G+25RPM WITH NO BRAKE, AT RT. EXCEPT FOR THE NON-SUBSTANTIALLY INCREASED CENTRIFUGATION FORCE, THIS CORRESPONDS TO THE PROTOCOL RECOMMENDED BY MILTENYI AND SHOULD THEREFORE HAVE NO NEGATIVE INFLUENCE ON THE LABELING OF THE CD34 POS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002272 ↗
• MalfunctionMay 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT RUN, CD34 ENRICHMENT WITH TSLS. A PUMP STALL ERROR OCCURRED WITH ~8 MIN LEFT IN PROCESS. USER OPENED PUMP DOOR AND DID NOT NOTICE ANY ISSUE (IE COLLAPSED TUBING OR BLOCKAGE). FINAL RECOVERED PRODUCT WAS 22ML AND HAD LOWER THAN EXPECTED CELL NUMBERS. RUNNING THE EMERGENCY PROGRAM TWICE DID NOT RESULT IN ENOUGH CELLS FOR TREATMENT. PATIENT DID NOT RECEIVE TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 11789241 ↗
• MalfunctionApr 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER COMPLAINED A LOW RECOVERY OF A CD34 SEPARATION. THE PATIENT COULD NOT BE TREATED WITH THIS CELLULAR PRODUCT, BUT WAS TREATED WITH AN ALTERNATIVE TREATMENT. 18% RECOVERY IN 59ML ELUTION VOLUME.

  Patient problems: Insufficient Information

  MAUDE report 11663912 ↗
• MalfunctionJul 8, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER COMPLAINED A LOW ELUTION VOLUME AND LOW RECOVERY OF A CD34 SEPARATION. THE PATIENT COULD NOT BE TREATED. TO OUR INFORMATION IT WAS CONSIDERED TO RE-COLLECT THE DONOR TO REPEAT THE CD34 SEPARATION. AS THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE REAGENT, A COMPLAINT RATE COULD NOT BE CALCULATED. HOWEVER, SUCH INCIDENTS ARE VERY RARE. AN ANALYSIS OF THE PROCESS CODE SHOWED THAT THE PROCESS WAS FINISHED WITHOUT ERROR CODES. HOWEVER, THE SAMPLE LOADING TIME WAS UNUSUALLY HIGH AND THE VOLUMES AFTER SEPARATION DID NOT FIT THE EXPECTED RANGE. THE CUSTOMER INDICATED THAT THE FLUID PATHWAY MIGHT HAVE BEEN PARTIALLY BLOCKED. THIS EXPLAINS OR AT LEAST CONTRIBUTED TO THE LOW VOLUME AND LOW RECOVERY. THE HIGH LOADING TIME IS PROBABLY DUE TO SAMPLE MATERIAL OLDER THAN RECOMMENDED AND VALIDATED (41H VS. 24H). THIS INCREASES THE RISK FOR AGGREGATES WHAT AGAIN HAS INFLUENCE ON THE ELUTION VOLUME AND RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10245050 ↗
• MalfunctionMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A LOW RECOVERY (30%) AND PURITY (60%) FOR A CD34 SEPARATION IN AN AUTOLOGOUS SETTING FOR A NEUROBLASTOMA PATIENT. NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING THE SEPARATION RUN. ALSO THE VOLUME OF THE TARGET FRACTION WAS AS EXPECTED. THE NUMBER OF TARGET CELLS IN THE STARTING MATERIAL WAS LOW WITH 1.8X106 CD34 POSITIVE CELLS. THE PATIENT WAS NOT TREATED WITH THE PRODUCT. AN INVESTIGATION CONCLUDED THAT THERE IS NO HINT FOR A PRODUCT MALFUNCTION OR USER ERROR BUT THAT RATHER THE COMPOSITION AND CHARACTERISTICS OF THIS STARTING MATERIAL LEAD TO THE DISSATISFYING RESULTS. THE FREQUENCY OF CD34+ CELLS IN THE STARTING MATERIAL WAS VERY LOW AND THE MATERIAL WAS DERIVED FROM A PRE-TREATED PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9852809 ↗
• MalfunctionSep 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER PERFORMED AN AUTOLOGOUS CD34 ENRICHMENT WITH LOW NUMBER OF CD34 CELLS IN BEGINNING (42X10E6) FROM TOTAL 2.4X10E10 WBCS. PROCESS CONTROL CODE WAS FINE. THE TARGET OBTAINED 11.4X10E8 TOTAL CELLS WITH ONLY A CD34 PURITY OF 1%. THIS IS IN TOTAL 11.8X10E6 CD34 CELLS AND A CD34 YIELD OF 28%. BOTH, THE PURITY AND YIELD DOES NOT MATCH THE CUSTOMERS AND PATIENTS NEED. FINALLY, THE PATIENT WAS NOT TREATED WITH AN EXPERIMENTAL TREATMENT. NO MORE INFORMATION ON THE PATIENT WAS PROVIDED BY THE CUSTOMER. THE INVESTIGATION REVEALED A SUBOPTIMAL STARTING MATERIAL WITH A VERY LOW FREQUENCY OF STEM CELLS AND A LOW TOTAL NUMBER OF CELLS. THIS HAS A HUGE INFLUENCE ON THE PERFORMANCE. IMPORTANT DATA TO FULLY UNDERSTAND THE CASE WERE NOT DELIVERED BY THE CUSTOMER (ANALYSIS OF WASTE FRACTION).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9098156 ↗
• MalfunctionMay 5, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER COMPLAINED THAT THE RECOVERY OF CD34+- CELLS WAS LOW (3.3%) FOR A CLINIMACS® SEPARATION PROCEDURA.

  Patient problems: No Information

  MAUDE report 5635406 ↗
• MalfunctionMay 5, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER COMPLAINED THAT THE RECOVERY OF CD34+-CELLS WAS LOW (3.3%) FOR A CLINIMACS SEPARATION PROCEDURE.

  Patient problems: No Information

  MAUDE report 5634846 ↗
• MalfunctionMar 1, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER COMPLAINED THAT THE VIABILITY OF CD34+ CELLS WAS LOW (19%) FOR A CD34 SEPARATION PROCEDURE. REGULARLY CLINICIANS PERFORM THE CELL TRANSPLANTATION EVEN IF THE SPECIFICATION FOR THE CELLULAR PRODUCT ARE POOR. THERE IS NO ADDITIONAL RISK FOR THE PATIENT. (B)(6).

  Patient problems: No Information

  MAUDE report 5469989 ↗
• MalfunctionMar 1, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER COMPLAINED THAT THE PURITY OF CD34+ CELLS WAS LOW (94%) FOR A SEPARATION PROCEDURE USING THE CLINIMACS CD34 SYSTEM. THE USER DECIDED TO USE THE PRODUCT BECAUSE MOST T CELLS ARE FOUND IN THE NEGATIVE FRACTION. THERE WAS NO RISK TO PATIENT. THIS EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5469984 ↗
• MalfunctionJan 14, 2016Device Issue; Device Issue

  THE CUSTOMER COMPLAINED THAT THE RECOVERY OF CD34+ CELLS WAS LOW (ABOUT 20%) FOR A SEPARATION PROCEDURE. ALSO, RE-LABELING AND RE-SELECTION OF THE NEGATIVE FRACTION (AFTER OVERNIGHT STORAGE) WAS NOT SUCCESSFUL. THIS EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5367492 ↗