BD MultitestRecalls & reported problems across all models

We found 4 models of BD Multitest by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2020 and Jul 26, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Multitest recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

2. Oct 3, 2022Open, Classified

   Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

   Z-0173-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BD Multitest problems

BD Multitest models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Multitest 662995

  Counter, differential cell
  2 recalls1 report
• BD Multitest™ 337166

  Counter, differential cell
  1 recall11 reports
• BD Multitest 662967

  Counter, differential cell
  1 recall8 reports
• BD Multitest 340499

  Counter, differential cell
  1 report

Recent BD Multitest adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED YJAY AFTER USING BD MULTITEST¿, ERRONEOUS RESULTS WERE ACQUIRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOT(76010) ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761 1. IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO. 2. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916358 ↗
• MalfunctionMar 15, 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. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT (34028) IS STAINED, IN THE CD45 VS SSC , CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT: 34028. THIS WILL CAUSE INCORRECT RESULT FOR BOTH CD4+ AND CD8+% AND CELL COUNTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914887 ↗
• MalfunctionMar 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD MULTITEST¿ 58 OCCURRENCES OF ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF PATIENT INFORMATION OR IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE) 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. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IND IS EXPERIENCING AN INTERMITTENT ISSUE WITH AN ISSUE WITH OUR TBNK RUNS (AS SEEN BELOW; APOLOGIES FOR THE SCAN QUALITY). WE ARE SEEING WHAT LOOKS TO BE AUTOFLUORESCENT POPULATIONS IN THE CD4/CD8 DOUBLE POSITIVE AND CD19/CD16+CD56 TRIPLE POSITIVE GATES. AS MENTIONED EARLIER IN THE EMAIL, THIS IS AN INTERMITTENT ISSUE SEEN IN BOTH THE QC AND SAMPLES. IT IS ACROSS SEVERAL INSTRUMENTS AND SPAS AS WELL AS SEEN IN MANUAL AND SPA PREPARATIONS OF THE SAMPLES. WE HAVE COMPLETED A QUICK TEST TO SEE IF A NEW LOT ON-SITE DOESN¿T PRESENT WITH THIS ISSUE. IT APP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18868341 ↗
• MalfunctionFeb 9, 2024Incorrect, 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 IVD REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC, CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679416 ↗
• MalfunctionJan 29, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE USING BD MULTITEST CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANTIBODIES CONTAMINATED WITH SUBSTANCE. THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 49506.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602795 ↗
• MalfunctionJan 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ 6-COLOR TBNK ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , APC VS SSC ,CD19 VS CD16+56 AND CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761. ADDITIONAL INFORMATION RECEIVED BY CUSTOMER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES, THAT IS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602631 ↗
• MalfunctionJan 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MULTITEST CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANTIBODIES CONTAMINATED WITH SUBSTANCE THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596934 ↗
• MalfunctionDec 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD STEM CELL CONTROL KIT 15 TESTS IVD THEY ACQUIRED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS RPOVIDED 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 18320074 ↗
• 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 ↗
• MalfunctionDec 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE WITH 2 KITS OF BD MULTITEST¿ TBNK W/TRUCOUNT SIGNIFICANT DEBRIS WERE SEEN ON CD45 VS SSC AND CD19 VS SSC COMPARING WITH THE OTHER FROM THE SAME LOT. BOTH WERE ON THE SAME PATIENT, THERE WAS NO REPORT OF IMPACT TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 KITS FROM LOT #30568 HAVE BE FOUND QUESTIONABLE DOT PLOTS, A SIGNIFICANT DEBRIS WERE SEEN ON CD45 VS SSC AND CD19 VS SSC COMPARING WITH THE OTHER FROM THE SAME LOT. BOTH OF THEM ARE USED THE SAME PATIENT EDTA BLOOD FOR STAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984329 ↗
• MalfunctionJul 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE RUNNING PATIENT SAMPLE WITH BD MULTITEST¿THERE WAS ABNORMAL BEHAVIOR IN STAINING. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE USER INDICATES THAT WHEN THE SAMPLE IS ACQUIRED IN THE GRAPHS THE GRANULOCYTE POPULATION IS NOT SHOWN. REMOTE ASSISTANCE WAS PERFORMED TO REVIEW THE SAMPLE ACQUISITION READINGS. THE READINGS WERE MADE WITH THE MULTITEST REAGENT WITH LOT NUMBER: 43889. THE REPORTS WITH THIS LOT SHOWED AN ABNORMAL BEHAVIOR IN THE STAINING. SAMPLES WERE STAINED WITH A DIFFERENT LOT OF REAGENT, WHICH CORRECTED THESE READINGS. ANNEX EVIDENCE AND REAGENT LOT NUMBER. -TYPE OF SAMPLES: PATIENTS: -NO RESULTS WERE ISSUED TO THE PATIENT SINCE IT WAS DETECTED AT THE TIME OF ANALYSIS. IT DID NOT AFFECT TREATMENT, THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12248395 ↗

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