BD Multitest™ 337166Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903371662), received between Jul 31, 2020 and Jul 26, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 8, 2024Open, Classified

   Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

   Z-2351-2024 · Root cause: Material/Component Contamination · FDA record ↗

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.

• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS OCCURRED ON PATIENT SAMPLE AND NO INJURIES OR TREATMENT HAVE BEEN REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXACT DATE IS NO LONGER TRACEABLE BY THE CUSTOMER, BUT WAS CONFIRMED TO HAVE OCCURRED WITHIN JUNE2024. PROBLEM WITH THE TRUCOUNT - THERE SEEMS TO BE TOO LOW NUMBER OF BEADS INSIDE, THIS RESULTED IN TOO HIGH ABSOLUTE COUNTING RESULTS THAT WERE NOT REALISTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841244 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST¿, ERRONEOUS RESULTS OCCURRED ON PATIENT SAMPLE AND NO INJURIES OR TREATMENT HAVE BEEN REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXACT DATE IS NO LONGER TRACEABLE BY THE CUSTOMER, BUT WAS CONFIRMED TO HAVE OCCURRED WITHIN (B)(6) 2024. PROBLEM WITH THE TRUCOUNT - THERE SEEMS TO BE TOO LOW NUMBER OF BEADS INSIDE, THIS RESULTED IN TOO HIGH ABSOLUTE COUNTING RESULTS THAT WERE NOT REALISTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841242 ↗
• MalfunctionJul 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS ON PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEM WITH THE TRUCOUNT - THERE SEEMS TO BE TOO LOW NUMBER OF BEADS INSIDE, THIS RESULTED IN TOO HIGH ABSOLUTE COUNTING RESULTS THAT WERE NOT REALISTIC." 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES, WRONG PATIENT RESULTS WERE SEND TO LIS, WHERE PHYSICIANS HAD ACCESS TO. ONE DOCTOR CONTACTED US, QUESTIONING THE RESULTS. IN OTHER OCCASIONS WE INTERCEPTED THE WRONG DATA OURSELVES LATER IN THE AUTHORISATION-PROCESS. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO, NOT THAT WE KNOW OF. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO SAMPLES WERE REDRAWN. THE REQUESTED TESTS WERE REPEATED ON THE SAMPLE THAT WAS ALREADY AVAILABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NOT THAT WE KNOW OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824492 ↗
• MalfunctionSep 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD MULTITEST¿, THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES INVOLVED? NO, THIS IS A TEST ON NORMAL BLOOD FOR POSSIBLE SET UP OF A NEW PROTOCOL TO GET THE % LYMPHOCYTES TCELLS & CD4 /CD8 RATIO IN BRONKEO ALVEOLAR LAVAGE(BAL) IS A CONFIRMATORY TEST ALWAYS PERFORMED? NO NOT AT THIS POINT WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES, WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397444 ↗
• MalfunctionMay 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSLYRIC¿ ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPARED WITH 2 DIFFERENT SYSMEX BLOOD COUNT INSTRUMENTS, THE LYMPHOCYTE ABSOLUTE VALUES WERE TOO HIGH ON FACSLYRIC. THEY USED TRUCOUNT LOT 21280 AND 6CTBNK+TRUC IN FACSUITE CLINICAL SOFTWARE FOR THE MEASUREMENTS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458381 ↗
• MalfunctionJul 13, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE IFU WAS MISSING FROM PACKAGING OF BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE CUSTOMER GOT THE NEW LOT OF THE REAGENT AND THE IFU WERE MISSING IN THE PACKAGE. ONLY A NOTE ABOUT STORAGE CONDITIONS WAS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162508 ↗
• MalfunctionJun 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MULTITEST¿ THERE WAS AN ABSENCE OF LYMPHOCYTES EVENTS. SAMPLES WERE RE-PREPARED WITH NEW VIAL OF SAMPLE LOT WITH OPTIMAL STAINING PATTERNS. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLES ACQUIRED WITH CANTO SW (TBNK+TRUC ) SHOWED ABSENCE OF LYMPHOCYTES EVENTS. ONLY TRUCOUNT WERE VISIBLE AND WELL POSITIONED ON THE PLOT. SAMPLES WERE RE-PREPARED BUT SHOWED ALWAYS THE SAME PATTERN. A NEW VIALS OF THE SAME LOT WERE USED TO RE-PREPARE THE SAME SAMPLE AND SHOWED AN OPTIMAL STAINING PATTERN. NO RESULT WERE SENT TO PATIENT. ALL SAMPLES ARE GOING TO BE PREPARED WITH THE GOOD NEW VIAL OF THE SAME LOT. PROBABLY A SIGNAL DEGRADATION OCCURRED FOR UNKNOWN REASONS IN THE OLD VIAL AFTER VIAL OPENING . WAS THE EVENT CAUSED BY A USE ERROR? NO IT WASN'T. IT IS NOT USE ERROR, THE REAGENT IS DAMAGED. DID THE PATIENT/MEDICAL PROVIDER PERCEIVE RESULTS TO BE CORRECT AND REPORT THEM? NO. IF APPLICABLE, IS THERE A CONFIRMATORY TEST STANDARD PROCEDURE? THEY JUST REPEATED THE TEST WITH A DIFFERENT REAGENT COMING FROM A DIFFERENT VIAL, AND RESULTS WERE VISIBLE ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084383 ↗
• MalfunctionMay 25, 2021Low Readings; Low Readings

  IT WAS REPORTED WHILE TESTING WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. TESTING WITH A DIFFERENT LOT# PROVIDED ACCURATE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: LOT 15789 NOT EFFICIENT, SAME SAMPLE TESTED WITH ANOTHER LOT GAVE GOOD RESULTS. ABNORMAL DOUBLE POPULATION CD56+CD19+.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878127 ↗
• MalfunctionNov 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH A 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES SOME EVENTS ARE NEAR THE AXIS AND THERE IS BAD SEPARATION ON PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED AND THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS CONCERNED ABOUT TANDEM DEGRADATION IN THE VIALS. AFTER HAVING ANALYZED THE DATA WE SEE SOME EVENTS ARE NEAR TO THE AXES: BAD SEPARATION. DATA CONTAIN CONTROL WITH ¿GOOD¿ AND ¿BAD¿ VIAL/LOT + SAMPLE WITH ¿GOOD¿ AND ¿BAD¿ VIAL/LOT WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? R: YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? R: OBTAINED AND NOT USED. IN THE VALIDATION IN CANTO SOFTWARE THE RESULT WAS NOT ACCEPTED. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? R: NO. NO RESULT WAS SENT OUT OF THE LAB. WAS THERE ANY HARM TO THE PATIENT? R: NO HARM. JUST DELAY ON NEW PREPARATION AND RE-RUN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770813 ↗
• MalfunctionOct 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH A 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES ERRONEOUS RESULTS OCCURRED ON PATIENT SAMPLES. RESULTS WERE NOT REPORTED, AND THERE WAS REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS CONCERNED ABOUT TANDEM DEGRADATION IN THE VIALS. AFTER HAVING ANALYZED THE DATA WE SEE SOME EVENTS ARE NEAR TO THE AXES BAD SEPARATION DATA CONTAIN CONTROL WITH ¿GOOD¿ AND ¿BAD¿ VIAL/LOT + SAMPLE WITH ¿GOOD¿ AND ¿BAD¿ VIAL/LOT COULD BE THIS REPORTED ISSUE HAVE PROVOKED ERRONEOUS RESULTS? IF YES, COULD YOU PLEASE ANSWER THE FOLLOWING QUESTIONS? WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? R: YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? R: OBTAINED AND NOT USED. IN THE VALIDATION IN CANTO SOFTWARE THE RESULT WAS NOT ACCEPTED. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? R: NO. NO RESULT WAS SENT OUT OF THE LAB WAS THERE ANY HARM TO THE PATIENT? R; NO HARM. JUST DELAY ON NEW PREPARATION AND RE-RUN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734470 ↗
• MalfunctionJul 31, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CD4 POSITIVE T CELLS ARE NOT VISIBLE AFTER USE WITH A 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: CD4 POSITIVE T CELLS ARE NOT VISIBLE IF SAMPLE IS PREPARED WITH REAGENT 6 COLOR TBNK LOT NUMBER 93090 WHILE CD4+ CELLS ARE PRESENT WHEN THE SAMPLE IS STAINED WITH 6-COLOR TBNK LOT NUMBER 32846. ( % CD3+CD4+ 2,56% VS 42,69; CD3+CD4+ ABS 71,55 VS 1147,92). ADDITIONALLY, ON 2020-7-23 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE EVENT CAUSED BY A USE ERROR? NO. DID THE PATIENT/MEDICAL PROVIDER PERCEIVE RESULTS TO BE CORRECT AND REPORT THEM? NO IF APPLICABLE, IS THERE A CONFIRMATORY TEST STANDARD PROCEDURE? YES, CUSTOMERS REPEATED THE TEST TO CONFIRM THE SAME RESULT AND THEN THEY REPEATED THE TEST USING ANOTHER LOT OF THE SAME REAGENT TO CONFIRM THE ERRONEOUS RESULT COMING FROM THE FIRST LOT. WAS A PATIENT TREATED BASED ON ERRONEOUS RESULTS? NO. WAS THERE ANY ADVERSE IMPACT TO THE PATIENT DUE TO THE TREATMENT? NO. IF CUSTOMER WAS HARMED/INJURED, PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO INJURY. WAS THERE ANY DELAY IN DIAGNOSIS OR TREATMENT DUE TO THIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350140 ↗