BD Multitest 662967Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382906629678), received between Dec 13, 2023 and Mar 15, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗