BD MAX™ MRSA XT 443461Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382904434618), received between Aug 20, 2021 and Aug 21, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 17, 2019Class IITerminated

   The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

   Z-2334-2019 · Root cause: Process control · Recall details · 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.

• MalfunctionAug 21, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT A SAMPLE THAT WAS NEGATIVE CAME BACK POSITIVE VIA PCR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING VERIFICATION OF MRSA XT TEST ON BD MAX, WE HAVE A SAMPLE THAT WAS NEGATIVE IN MRSA XT AND ALSO IN OUR COMPARISON METHOD EASYPLEX MRSA (AMPLEX). ACCORDING TO CULTURE, IT WAS AN MRSA (ALREADY KNOWN). WE SENT SAMPLE TO THE PARTNER LABORATORY FOR MRSA-PCR: POSITIVE THERE. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591881 ↗
• MalfunctionAug 8, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT, THERE WAS A FALSE NEGATIVE OF MRSA. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RESULTS IN TWO CASES WITH MRSA XT KIT, MECA/MECC WAS DETECTED, BUT MREJ CASSETTE WAS NOT. RESULT BD MAX IS MRSA NEGATIVE. ALL OF THESE SPECIMENS TESTED POSITIVE IN CULTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483642 ↗
• MalfunctionAug 1, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER NEGATIVE RESULTS ON THE BD MAX, DUE TO LACK OF DETECTION OF THE MEC RIGHT EXTREMELY JUNCTION (MREJ) REGION. CULTURE SAMPLES WERE MEASURED ON THE BD MAX, ONLY MECA AND MECC WERE DETECTED. MRSA RESULT BY BD MAX WAS NEGATIVE. THEN THE SAME SAMPLES WERE MEASURED ON THE CEPHEID DEVICE (MECA/C AND SCC POSITIVE. RESULT INTERPRETED AS POSITIVE) THE PBP2 TEST FROM BACTERIOLOGY ALSO GAVE A POSITIVE MRSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438658 ↗
• MalfunctionOct 26, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ALMOST 25% FALSE POSITIVES FOR PRODUCT 443461."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677228 ↗
• MalfunctionAug 17, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT ONE SAMPLE FALSELY CLASSIFIED NEGATIVE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER DURING USE 1 SAMPLE WAS FALSELY CLASSIFIED BY THE BD MAX AS A NEGATIVE MRSA SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246222 ↗
• MalfunctionAug 5, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. CONFIRMATORY TESTING PRODUCED NEGATIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HOWEVER, ABOUT 60% OF THE SAMPLES DETECTED POSITIVE WITH BD MAX AND CEPHEID MRSA WERE NEGATIVE IN CULTURE (MICROBIOLOGY)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180276 ↗
• MalfunctionDec 17, 2021False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A FALSE NEGATIVE RESULT WHILE USING CAT 443461 LOT 1203082. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13031535 ↗
• MalfunctionOct 15, 2021False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE BD MAX¿ MRSA XT PRODUCED THREE FALSE NEGATIVE MRSA RESULTS. NASAL SWABS WERE CULTURED THAT TYPED THE RESULTS AS CC1 MRSA IV CLONES; THESE CC1-MECA TYPE IV STRAINS WERE NOT RECOGNIZED BY THE INSTRUMENT DUE TO AN INSERTION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE FALSE NEGATIVE MRSA XT RESULTS IN THE PAST FOUR MONTHS, THREE PATIENTS WERE DIAGNOSED WITH FALSE NEGATIVE MRSA RESULTS USING OUR MRSA XT KIT. IN EACH OF THE THREE PATIENTS, AN MRSA STRAIN COULD SUBSEQUENTLY BE CULTURED FROM THE NASAL SWABS. ONE OF THESE STRAINS WAS TYPED BY THE NATIONAL REFERENCE CENTER. IT IS A SO-CALLED CC1 MRSA IV CLONE. A CC1-MECA TYPE IV STRAIN IS DESCRIBED WHICH IS NOT RECOGNIZED BY THE BD-MAX DUE TO AN INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643694 ↗
• MalfunctionAug 20, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD MAX" MRSA XT 2 PATIENT SAMPLES OBTAINED (B)(6) RESULTS. BOTH SAMPLES WERE REPEATED AND THE ISSUE REMAINED. SAMPLES WERE SENT OUT FOR CULTURE, RESULTS HAVE NOT BEEN REPORTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE RESULT PROVIDED DOES NOT MATCH THE GRAPH FOR CAT 443461. BOTH SAMPLES WERE REPEATED AND THE SAME ISSUE OCCURRED. RESULTS HAVE NOT BEEN RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351136 ↗