BD Phoenix™ AST Indicator Solution 246004Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 30382902460047), received between Feb 4, 2021 and Nov 26, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

4 other recalls cover devices cleared under the same FDA submission (K020321); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED DURING USE OF BD PHOENIX¿ AST INDICATOR SOLUTION, A TEST ABORT DUE TO INSUFFICIENT INDICATOR OCCURRED AND THE CUSTOMER BELIEVES THE PRODUCT WAS MISLABELED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779941 ↗
• MalfunctionMar 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AST INDICATOR SOLUTION THAT THERE WAS A LEAK IN A BROKEN BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AST INDICATOR VIAL WAS LEAKED, INDICATOR SOLUTION HAS SPILLED OUTSIDE OF VIAL WHEN CUSTOMER OPENED POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475505 ↗
• MalfunctionMar 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AST INDICATOR SOLUTION THAT THERE WAS A LEAKING BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDICATOR VIAL WAS LEAKED, INDICATOR SOLUTION HAS SPILLED OUTSIDE OF VIAL WHEN CUSTOMER OPENED POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475504 ↗
• MalfunctionMay 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD PHOENIX¿ AST INDICATOR SOLUTION HAD AN INSUFFICIENT AMOUNT OF INDICATOR ON THE PANEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "PHOENIX ISSUES ¿INSUFFICIENT AMOUNT OF INDICATOR DETECTED ON PANEL¿ ALARM ON 5 PANELS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337994 ↗
• MalfunctionApr 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD PHOENIX¿ AST INDICATOR SOLUTION HAD PERFORMANCE ISSUES WITH THE DROPLETS ON THE PHX PANELS VARYING GREATLY, CAUSING THE SYSTEM TO STOP ITS RUN. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DROPLETS VARY A LARGE DEGREE, THAT PHX RUNS ARE STOPPED BECAUSE OF THE VARIATION IN THE AMOUNT OF INDICATOR. THE DROPLETS WERE PLACED INTO THE PHX PANELS, HOWEVER THE AMOUNT OF INDICATOR VARIED SO MUCH, THE SYSTEM STOPPED RUNS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994216 ↗
• MalfunctionFeb 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD PHOENIX¿ AST INDICATOR SOLUTION THERE WAS A PERFORMANCE ISSUE - ATYPICAL GROWTH, ATYPICAL REACTION, FAILURE TO INHIBIT, INSUFFICIENT GROWTH, POTENCY, PH FAILURE FOR PREPARED REAGENTS/MEDIA THAT COULD IMPACT GROWTH PERFORMANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "AN ERROR IN WHICH THE COLOR HAS FADED AND WOULD LIKE TO KNOW IF THIS ISSUE OCCURRED AT OTHER FACILITIES WITH THE SAME LOT, THE CAUSE OF THE INDICATOR SOLUTION ERROR, AND IF THERE IS SOME WAY TO PREVENT THIS ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545933 ↗
• MalfunctionDec 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 2 BD PHOENIX¿ AST INDICATOR SOLUTIONS ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. 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: " INSUFFICIENT AMOUNT OF INDICATOR DETECTED ON PANEL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13055954 ↗
• MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. 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: " REPORT AN INCREASE IN CASES OF PANEL ABORTION DUE TO ALARM: INSUFFICIENT AMOUNT OF INDICATOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436743 ↗
• MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AST INDICATOR SOLUTION HAD ATYPICAL GROWTH THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " REPORT AN INCREASE IN CASES OF PANEL ABORTION DUE TO ALARM: INSUFFICIENT AMOUNT OF INDICATOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436687 ↗
• MalfunctionAug 10, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST INDICATOR SOLUTION INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE OUTER BOX AND INNER PACKAGING DATE ARE DIFFERENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305322 ↗
• MalfunctionJul 22, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST INDICATOR SOLUTION AN INCORRECT EXPIRATION DATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER IS REPORTING THAT THE EXPIRATION ON THE BOX AND INDIVIDUAL BOTTLE ((B)(4)2022) DO NOT MATCH THE EXPIRATION ON THE INDIVIDUAL BAGS ((B)(4)2020). "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212710 ↗
• MalfunctionJul 19, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT WHILE USING 153 BD PHOENIX¿ AST INDICATOR SOLUTIONS INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EXPIRATION DATE SHOWN ON VIAL LABEL IS 30 APR 2020 WHILE THE EXPIRATION DATE SHOWN ON BOX LABEL AND COC IS (B)(6) 2022. END-USERS WILL NOT ACCEPT THIS ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193700 ↗
• MalfunctionJul 19, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH BD PHOENIX¿ AST INDICATOR SOLUTION THE INNER BAGS HAD WRONG INFORMATION. THIS OCCURRED WITH 153 BAGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRONG LABEL IN INNER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190423 ↗
• MalfunctionFeb 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST INDICATOR SOLUTION ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL IN 10 SAMPLES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 11319156 ↗
• MalfunctionFeb 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST INDICATOR SOLUTION A BROKEN BOTTLE WAS OBSERVED BY THE LABORATORY PERSONNEL. IN THE EVENT OF A BROKEN OR LEAKING BOTTLE, THERE IS POTENTIAL FOR INJURY AND EXPOSURE TO EYES, MOUTH, OTHER MUCOUS MEMBRANE, NON-INTACT SKIN, OR PARENTERAL CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11282342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020321. One submission often covers many models, so check the product and lot details in each record.

• Z-0239-2026 · Sep 23, 2025 · Open, Classified
  BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
• Z-0592-2025 · Oct 31, 2024 · Open, Classified
  BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
• Z-3247-2024 · Aug 1, 2024 · Open, Classified
  BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid re
• Z-3246-2024 · Aug 1, 2024 · Open, Classified
  BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provi