BD Multitest™ 644611Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382906446114), received between Sep 8, 2021 and Feb 22, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NON SPECIFIC POPULATION/DEBRI OBSERVED IN ALL PATIENT SAMPLES STAINED WITH THE BD 6-COLOUR TBNK REAGENT. REPEATED WITH NEW VIAL OF SAME REAGENT, ISSUE PERSISTS. CHANGED TRUCOUNT TUBES AND FACSLYSE SOLUTION, ISSUE PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763244 ↗
• MalfunctionDec 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS ARE BEING OBTAINED DUE TO UNUSUAL STAINING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LAB IS GETTING THESE NON-SPECIFIC STAINING ON TBNK RECENTLY. THEY DON'T KNOW WHAT COULD HAVE CAUSED IT, BUT THEY SUSPECT IT COULD BE CAUSED BY RBC TELOMERES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRE.) YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE?(GO TO QUESTION #3) NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANCE OR DELAY OF TREATMENT?(GO TO QUESTION #4) N/A, SAMPLES WERE NOT REDRAWN. 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 QUESTION REQUIRED): NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383027 ↗
• MalfunctionDec 12, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THERE WAS CONTAMINATION IN THE REAGENT DURING USE WITH THE BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENT CHANGE TO NEW LOT TBNK 49510, EXP 30.09.2024 REAGENT HAS FOUND MORE SAMPLES WITH MUCH HIGHER DEBRIS/NOISE LEVEL ON CD45 LOW VS SSC AND FCS. ALMOST ALL SAMPLES IN THE RUN HAVE THE DEBITS EXPRESS POSITIVE STAINING ON ALL THE MARKERS OF TBNK PANEL. WE¿VE ALREADY DONE MANY STEPS OF CLEANING AND TROUBLESHOOTING ON THE BD FACSCANTO II INSTRUMENT. DEBRI PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311974 ↗
• MalfunctionOct 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TBNK RUN WITH 1/3 OF PATIENTS SHOWING A SMALL PERCENTAGE OF CONTAMINATION. TBNK LOT 42267 EXP 30.06.2024, THIS BOTTLE WAS THE 1ST BOTTLE OF 8 WHICH WAS OPENED ON 29.09.23 FOR PRE-TESTING. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (ANSWER: YES). 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (ANSWER: NO). 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (ANSWER: N/A, PATIENT SAMPLES NOT REDRAWN.) 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (ANSWER: NO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017513 ↗
• MalfunctionSep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. COULD YOU PLEASE PROVIDE CONTAMINATION CHECKLIST? 2. COULD YOU PLEASE PROVIDE PATIENT SAMPLE CHECKLIST? 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? 1. WERE SAMPLES CONTAMINATED? = SAMPLES WERE NOT CONTAMINATED. 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.): 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE (GO TO QUESTION #3): 3. IF PATIENT SAMPLES WERE RE-DRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4.): 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): 5. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? (GO TO QUESTION #6.): 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.): 1. YES. 2. UNKNOWN. 3. PATIENT SAMPLES WERE RE-TESTED USING A NEW VIAL OF REAGENT. SAMPLES WERE NOT RE-DRAWN. 4. NO. STAFF OPENED A NEW BOTTLE OF TBNK 6 COLOUR REAGENT YESTERDAY AND NOTED A STRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839454 ↗
• MalfunctionSep 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRONEOUS RESULTS: YES. DETAILED ERRONEOUS RESULTS: RESULTS ARE NOT REPORTED, CUSTOMER HAS COMPARED BATCHES AND NOTIFIED ME OF THE PERFORMANCE ISSUE. CUSTOMER IS SEEING SOME NON SPECIFIC STAINING. THEY HAVE PROVIDED DATA ON A DIFFERENT LOT THAT LOOKS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683500 ↗
• MalfunctionJul 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD MULTITEST¿ THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE APC VS SSC AND CD4 VS CD8 GRAPHS, THERE IS NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262380 ↗
• MalfunctionApr 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD MULTITEST¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 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): NO. TBNK KIT PERFORMANCE ISSUE. CUSTOMER IS SEEING AGGREGATES IN THE FLUORESCENT CHANNELS, POTENTIAL AFFECTING REPORTING % OF CELL POPULATION. INSTRUMENT IS WORKING FINE ACCORDING TO ENGINEER. ANALYZED THE DATA AND CAN SEE THE POPULATION- WHICH IS ATTACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727578 ↗
• MalfunctionSep 8, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE PACKAGE INSERT WAS MISSING WITH A BD MULTITEST". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SINCE THE DELIVERY DID NOT INCLUDE ANY PACKAGE INSERTS AND SINCE WE, AS AN ACCREDITED LABORATORY, ARE REQUIRED TO CHECK ALL REAGENTS USED FOR CORRECT USE WITH THE AID OF THE PACKAGE INSERT, WE WANTED TO VIEW THE CURRENTLY VALID VERSION OF THE PACKAGE INSERT VIA YOUR HOMEPAGE. NO SERIOUS INJURY,NO ERRONEOUS RESULTS,NO COURSE OF TREATMENT CHANGED, NO EXPOSURE TO BLOOD/BODILY FLUID, SAFETY ISSUE INCL. NO NEEDLE STICK, NO MEDICAL INTERVENTION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441298 ↗