BD Phoenix™ AST-S Indicator Solution 246009Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30382902460092), received between Apr 9, 2021 and Apr 17, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K050745); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AST-S INDICATOR SOLUTION INSUFFICIENT INDICATOR ERROR OCCURRED WITH THE AST-S PANEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, AN INSUFFICIENT INDICATOR ERROR OCCURRED WITH THE AST-S PANEL. IT OCCURRED IN A RE-TEST. IN ANOTHER RE-TEST WITH A NEW PRODUCT, THE SAME ERROR OCCURRED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752026 ↗
• MalfunctionJul 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN USING THE BD PHOENIX¿ AST-S INDICATOR SOLUTION, THE PROPER REAGENT AMOUNT WOULD NOT AFFORD A REACTION AND INSUFFICIENT, SOLUTION ERROR WOULD DISPLAY. THIS IS A REPORT OF A SINGLE OCCURRENCE. THERE WERE NO RESULTS TO REPORT OUT TO THE CLINICIAN OR TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, EVEN THOUGH THE CUSTOMER DRIPS THE PROPER AMOUNT OF THE INDICATOR SOLUTION, AN INSUFFICIENT SOLUTION ERROR IS DISPLAYED AND RESULTS CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962328 ↗
• MalfunctionJul 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION A PERFORMANCE ISSUE OCCURRED. THIS OCCURRED 6 TIMES. 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: AFTER ONE DROP OF ZHURONG AST INDICATOR IS PUT ON THE MACHINE, THE INSTRUMENT SHOWS THAT THE INDICATOR IS INSUFFICIENT, WHICH LEADS TO THE FAILURE OF THE ON-BOARD INTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958792 ↗
• 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-S 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. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "REPEATED FAILURES ON THE BD STREP PANELS 448785 WHEN USING STREP INDICATOR 246009. THE REASON ON EPICENTER FOR THE FAILURE IS INSUFFICIENT INDICATOR IN THE PANEL. CUSTOMER CONFIRMED THEY ARE ADDING 1 FULL DROP AND KEEP THE INDICATOR REFRIGERATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545030 ↗
• MalfunctionOct 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION THERE WERE MANY FAILURES IN SMIC GALLERIES. CONFIRMATORY TESTING WAS DONE USING AGAR PLATES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE HAD MANY FAILURES OF OUR SMIC GALLERIES. I INCRIMINATED THE REAGENT REF (B)(4). HAVING A NEW BATCH WE DID OUR ANTIBIOTIC SUSCEPTIBILITY TESTS WITH IT AND NO MORE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591609 ↗
• MalfunctionApr 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 15 BD PHOENIX¿ AST-S INDICATOR SOLUTION 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: "CUSTOMER IS REPORTING ABORTED PANELS DUE TO INSUFFICIENT INDICATOR. " MATERIAL NO: 246009 LOT NO: 0226723 IT WAS REPORTED THAT ABORTED PANELS DUE TO INSUFFICIENT INDICATOR OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050745. One submission often covers many models, so check the product and lot details in each record.

• Z-0935-2019 · Dec 20, 2018 · Terminated
  Phoenix AP AST Indicator Bag, Catalog Number 246006
• Z-0934-2019 · Dec 20, 2018 · Terminated
  Phoenix AST Indicator, Catalog Number 246004
• Z-0933-2019 · Dec 20, 2018 · Terminated
  Phoenix AST-s Indicator, Catalog Number 246009