BD Phoenix™ AP AST Indicator Solution 246006Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382902460061), received between Aug 23, 2021 and Apr 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING THE BD PHOENIX¿ AP AST INDICATOR SOLUTION THE USER NOTED A MISMATCH IN THE PRODUCT AND CARTON LABEL STATING THE CATALOG NUMBERS WERE DIFFERENT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912841 ↗
• MalfunctionApr 17, 2026Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING THE BD PHOENIX¿ AP AST INDICATOR SOLUTION THE USER NOTED A MISMATCH IN THE PRODUCT AND CARTON LABEL STATING THE CATALOG NUMBERS WERE DIFFERENT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912828 ↗
• MalfunctionApr 17, 2026Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING THE BD PHOENIX¿ AP AST INDICATOR SOLUTION THE USER NOTED A MISMATCH IN THE PRODUCT AND CARTON LABEL STATING THE CATALOG NUMBERS WERE DIFFERENT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911010 ↗
• MalfunctionAug 10, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT PRIOR TO USE WITH THE BD PHOENIX¿ AP AST INDICATOR SOLUTION, THE LABEL WAS DAMAGED AND THE DEVICE CATALOG NUMBER WAS NOT LEGIBLE. THE NUMBER OF BOTTLES AFFECTED IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER DESCRIBED LEAKAGE OF THE AP AST INDICATOR IN THE POUCHES. NO SIGNIFICANT LOSS, BUT WATCHED AS A NEW ONE WAS OPEN AND LIKE THE ONE BEING REMOVED THE LABEL WAS DEFACED WITH THE BLUE COLOR OF THE INDICATOR. THERE HAS BEEN NO IMPACT TO INSTRUMENT PERFORMANCE OR PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204005 ↗
• MalfunctionFeb 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD PHOENIX¿ AP 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. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE RECENTLY STARTED USING A NEW INDICATOR LOT ON (B)(6) 2022 (LOT: 1145474, EXP: 30/6/22) AND NOTED THAT QC FOR GENTAMICIN ON E.COLI ATCC (B)(4) HAS PASSED THIS WHOLE WEEK. HOWEVER, WE HAVE CONTINUED TO PERFORM CONCURRENT DISC TESTING FOR GENTAMICIN AND NOTED THAT THERE ARE STILL DISCREPANCIES IN INTERPRETATION DESPITE QC PASSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545931 ↗
• MalfunctionSep 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP AST INDICATOR SOLUTION MISSING LABEL INFORMATION 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: "THE CUSTOMER FOUND A BOTTLE WITHOUT A LABEL THAT WAS ALSO LEAKING UPON UNPACKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436747 ↗
• MalfunctionAug 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP 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: "THIS IS A REPORT ABOUT A LABEL ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356804 ↗

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