BD Phoenix™ SMIC/ID-101 448802Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30382904488025), received between May 6, 2021 and Sep 30, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 reports).

3 other recalls cover devices cleared under the same FDA submission (K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported while using the BD Phoenix¿ SMIC/ID-101 an unspecified number of patient isolates were misidentified. No health impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946960 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394240 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394229 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394227 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391008 ↗
• MalfunctionDec 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - MRSA) WAS MISIDENTIFIED AS GROUP B STREP. REPEAT TESTING WAS PERFORMED CAUSING THE ISOLATE TO BE MISIDENTIFIED TWICE. THE USER NOTED THAT THE ISOLATE DID NOT APPEAR TO BE A STREP THEREFORE, THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY GIVING THE CONFIRMED RESULT OF MRSA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918966 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE WAS MISIDENTIFIED. THE USER NOTED THAT THE ISOLATE WAS HAD A LARGE ZONE OF BETA HEMOLYSIS, WAS CAMP TEST NEGATIVE, AND A DISC NEGATIVE. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637504 ↗
• MalfunctionNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS AGALACTIAE) WAS MISIDENTIFIED AS STREPTOCOCCUS CONSTELLATUS. THE USER NOTED THAT THE ISOLATE WAS CAMP TEST POSITIVE. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612047 ↗
• MalfunctionOct 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 THE USER NOTED MISIDENTIFICATIONS OF RESULTS. FURTHER INVESTIGATION DETERMINED THAT THE PATIENT RESULTS WERE BEING ALTERED BY THE USER'S LABORATORY INFORMATION SYSTEM (LIS). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463242 ↗
• MalfunctionJul 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREP PNEUMONIA) WAS MISIDENTIFIED AS STREP MITIS OR AS AN UNIDENTIFIED ORGANISM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646755 ↗
• MalfunctionOct 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ SMIC/ID-101 THERE WAS MISIDENTIFICATION. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: SPECIMEN LAB REPORT AND BINARY FILE HAS BEEN ADDED TO (B)(4). WERE THIS PATIENT SAMPLES? IF SO, WHAT RESULTS WERE REPORTED? THE DISCREPANCIES WERE ALL PATIENT SAMPLES. I BELIEVE MOST OF THE INCORRECT ID'S WERE CAUGHT BEFORE REPORTING THEM OUT BUT IT IS VERY EASY FOR THEM TO SLIP BY WHEN YOU'RE DEALING WITH LARGE NUMBERS OF RESULTS. WAS PATIENT TREATMENT AFFECTED AND WERE THERE ANY ADVERSE EVENTS? N/A. CUSTOMER IS REPORTING MISIDENTIFICATION OF STREP ANGINOSUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936019 ↗
• MalfunctionJun 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WITH USE OF BD PHOENIX¿ SMIC/ID-101 THERE WAS MISIDENTIFICATION OF STREP A AS STREP B. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS MISIDENTIFICATION OF STREP A AS STREP B. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? Y. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): MISIDENTIFICATION ON SMIC PANEL. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? STREP B. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) STREP A. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? N/A. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. RESULT WAS RELEASE, BUT WAS CAUGHT EARLY BEFORE PATIENT CARE WAS AFFECTED. CORRECTED ACTION WAS PERFORMED BY THE FACILITY. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? N.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195899 ↗
• MalfunctionJun 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 2. IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ SMIC/ID-101 PANEL, STREP VIRIDANS WAS MISIDENTIFIED AS GROUP B STREP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ORGANISM MISIDENTIFICATIONS. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ISOLATE 2 - STREP VIRIDANS IDENTIFIED AS GROUP B STREP. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT)? ISOLATE 2 WAS NOT NOTED IF ANY REPEAT WAS PERFORMED. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT ISOLATES WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138270 ↗
• MalfunctionJun 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 1 OF 2 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ SMIC/ID-101 PANEL, STREP VIRIDANS WAS MISIDENTIFIED AS GROUP B STREP, AND AS LACTOCOCCUS UPON REPEAT TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ORGANISM MISIDENTIFICATIONS. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ISOLATE 1 - STREP VIRIDANS IDENTIFIED AS GROUP B STREP. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) ISOLATE 1, WAS REPEATED AND IDENTIFIED AS LACTOCOCCUS WHICH ALSO WAS NOT CORRECT. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT ISOLATES. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO. ISOLATE 1 - TAKEN FROM REMEL CHOCOLATE AGAR LOT 651343.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138248 ↗
• MalfunctionOct 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ SMIC/ID-101 MISIDENTIFICATION OCCURRED WHILE RUNNING PANEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING MISIDENTIFICATION WHEN RUNNING PANEL 448802, LOT 2074478. CUSTOMER STATED THAT SPECIMEN WAS SET UPWITH OPTOCHIN DISC AND THE RESULT WAS POSITIVE. THEY SENT THE SPECIMEN TO ARUP FOR DEFINITIVE ID USING THE MALDI AND THE RESULT WAS STREP PNEUMONIAE. THEY WILL BE SENDING THE ISOLATE FOR INVESTIGATION. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? STREP MITIS. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) STREP PNEUMONIAE. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? CLINICAL SPECIMEN. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO, CUSTOMER STATED, "REPORTED AS GRAM POSITIVE ORGANISM, WITH ADDED COMMENT OF, ¿ISOLATE SENT TO REFERENCE LABORATORY FOR DEFINITIVE ID AND SUSCEPTIBILITY TESTING.¿ 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674510 ↗
• MalfunctionMay 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ SMIC/ID-101 A MIS-ID WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT MIS-ID OF STREP PEUNO TO STREP MITIS OCCURRED. NITASHA ASSI : 2021-04-12 18:07:55 (GMT) ¯ CUSTOMER PROBLEM: CUSTOMER REPORTING MIS-ID OF STREP PEUNO TO STREP MITIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206. 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