BD EpiCenter™ Data Management System 441007Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382904410070), received between Feb 17, 2021 and Jun 5, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 31, 2024Open, Classified

   BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

   Z-0584-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN USING THE BD EPICENTER¿ SINGLE USER SOFTWARE, DUE TO A NURSE'S ERROR, THE ACCESS NUMBER WAS INCORRECTLY LINKED TO THE WRONG PATIENT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467137 ↗
• MalfunctionOct 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD EPICENTER¿ SINGLE USER SOFTWARE, A PATIENT RESULT WAS MISASSOCIATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS THEIR PATIENT MRN IN EPICENTER IS BELONGS TO DIFFERENT PATIENT VIA THEIR LIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935947 ↗
• MalfunctionOct 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD EPICENTER¿ SINGLE USER SOFTWARE, PATIENT RESULTS WERE MISASSOCIATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: PROBLEM ASSOCIATING ACCESS NUMBER (B)(4) WITH THE RIGHT REGISTRY. EPICENTER CONTINUES TO SHOW A PATIENT FROM 2022 WITH THE ACCESSION NUMBER MENTIONED ABOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917007 ↗
• MalfunctionSep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED HAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE THERE WAS MISASSOCIATION PATIENT TO SPECIMEN MISASSOCIATION SPECIMEN TO TEST MISASSOCIATION OF DATA TEST TO RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT EPICENTER RECEIVED OLD PATIENT DEMOGRAPHICS FOR A RECYCLED ACCESSION NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740527 ↗
• MalfunctionAug 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, MISASSOCIATED DATA OF ONE SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ERROR 21220: THE SAME ORGANISM ID FOR ISOLATE NUMBER 3 ASSIGNED TO SAMPLE X COLLECTED ON (B)(6) 2023 WAS ISOLATED FROM THE SAME PATIENT ON (B)(6) 2023 FOR SAMPLE Y. THE TEST HAS ALREADY BEEN REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597672 ↗
• MalfunctionAug 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, THERE IS A MISASSOCIATION OF DATA LINKED TO ONE SPECIMEN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DOCTOR REPORTS AN ANOMALY WHEREBY, FOR EXAMPLE, IF A BOTTLE IS POSITIVE, IT IS DISCHARGED AS POSITIVE BY THE INSTRUMENT - AND EPICENTER ALSO REPORTS IT AS POSITIVE. BUT THEN AS SOON AS OTHER VIALS LINKED TO THE SAME ACCESS NUMBER/PATIENT ARE FINALIZED, EPICENTER REPORTS ALL THE VIALS, INCLUDING THE ONE PREVIOUSLY DISCHARGED AND POSITIVE, AS NEGATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558837 ↗
• MalfunctionAug 3, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE AMIKACIN SUSCEPTIBILITY IS BEING INCORRECTLY INTERPRETED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPROTER: CUSTOMER IS REPORTING AMIKACIN SUSCEPTIBLITY IS BEING INCORRECTLY INTERPRETED BY EPICENTER. IT IS FALSELY RESULTING SUSCEPTIBLE ON RESULTS THAT SHOULD BE INTERMEDIATE TO PATIENT CHARTS, SO THIS IS VERY MUCH IMPACTING PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455491 ↗
• MalfunctionJul 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, THERE WAS MISASSOCIATION OF SEQUENCE NUMBER 449380113245. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ERROR 4005 RELATED TO SEQUENCE NUMBER 449380113245. MADE A CHANGE OF ASSOCIATION OF SAMPLES AS THE ACCESS NUMBER HAD BEEN READ AND REGISTERED INCORRECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370874 ↗
• MalfunctionJul 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD EPICENTER¿ SINGLE USER SOFTWARE, PATIENT DATA WAS ASSOCIATED INCORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: INCORRECT ASSOCIATION BLOOD CULTURES MASTER DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300983 ↗
• MalfunctionJul 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE THERE WAS MIS ASSOCIATION OF ONE PATIENT. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ERROR 2612 ASSOCIATION ERROR ERROR MESSAGE APPEARED THE DAY BEFORE AT 9:50 P.M., PREVIOUS MESSAGE: THE LIS HAS CHANGED THE NAME OF PATIENT X".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291840 ↗
• MalfunctionApr 12, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE ANTIBIOTICS ARE NOT BEING REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ACINETOBACTER THAT WAS RAN ON INSTRUMENT 1 AND MEROPENEM WAS NOT DONE BY PHOENIX. WE NEED TO CHECK AGAIN WHY INSTRUMENT 1 IS NOT DOING THE MEROPENEM BUT IT¿S DONE ON INSTRUMENT 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729096 ↗
• MalfunctionApr 5, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE REPORTS WILL NOT RECEIVE MIC FROM EPI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT MEROPENEM SOMETIMES REPORTS AND DO NOT ON ACINETOBACTER FOR NMIC 311 NO MIC RESULT DUE INSTRUMENT CONFIGURATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685909 ↗
• MalfunctionMar 2, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE PATIENT RESULTS WERE IMPACTED BY INCORRECT RESULTS FOR TETRACYCLINE RESISTANCE. CUSTOMER DID NOT PROVIDE INFORMATION ON TREATMENT CHANGE TO PATIENT OR AMOUNT OF SAMPLES AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONDED THAT ALL TETRACYCLINE RESULTS WHERE THE RULE WAS FIRED BETWEEN (B)(6) 2022 AND (B)(6) 2022 IMPACTED PATIENT RESULTS. TETRACYCLINE FOR ESBL ISOLATES WAS CHANGED TO RESISTANT AS A RESULT OF RULE 1487 FOR PATIENTS FROM (B)(6) 2022 TO (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475779 ↗
• MalfunctionSep 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD PROBLEMS FINALIZING A PANEL ON BD EPICENTER¿ SINGLE USER SOFTWARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "PROBLEMS FINALIZING A PANEL (IT IS FINALIZED BUT EPICENTER DOES NOT ALLOW FLAGGING TO SAVE). URGENT APPLICATION SUPPORT REQUEST SENT TO SPECIALISTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396909 ↗
• MalfunctionJun 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD EPICENTER¿ SINGLE USER SOFTWARE ACQUIRED MIS-ASSOCIATION DUE TO USE ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRONG ACCEPTANCE OF SAMPLES CLEAR PROBLEM/ EPICENTER FAILURE: NO. CAUSE OF EPICENTER FAILURE: EXTERNAL ERROR. RESOLUTION OF THE FAILURE/ WHAT WAS DONE TO RESOLVE THE EPICENTER FAILURE: THE NURSE WHO PERFORMED THE SAMPLING REVERSED THE ACCESS NUMBER LABELS ON THE BACTEC BOTTLES BY ENTERING THE RESERVATION OF THE AEROBIC BLOOD CULTURE ON THE ANAEROBIC BOTTLE AND THE ACCEPTANCE OF THE ANAEROBIC BLOOD CULTURE ON THE AEROBIC BOTTLE. HAS REVERSED THE ACCESS NUMBER LABELS ON THE BACTEC BOTTLES BY INSERTING THE RESERVATION OF THE AEROBIC BLOOD CULTURE ON THE ANAEROBIC BOTTLE AND THE ACCEPTANCE OF THE ANAEROBIC BLOOD CULTURE ON THE AEROBIC BOTTLE. SOLVED BY EXPLAINING TO THE CUSTOMER HOW TO ASSOCIATE THE RIGHT SAMPLE WITH THE RIGHT BOTTLE. VERIFIED WITH THE CUSTOMER PASSAGE OF THE RESISTANCE MARKERS AND NOTES TO THE REPORT. CHECKED FOR CORRECT OPERATION. INCORRECT LABELING BY NURSES OF BLOOD CULTURE SAMPLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628481 ↗
• MalfunctionDec 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT USER ERROR ON THE BD EPICENTER¿ SINGLE USER SOFTWARE CAUSED THE RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI TO BE SET AT 4 INSTEAD OF 8. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS NOTICED THAT THE BP FOR PUD V6.81 HAS BP FOR IMIPENEM ON ENTEROCOCCUS SPP. IS SET AT 4 INSTEAD OF 8. EUCAST 2020 SETS R>4 AND ON EPICENTER SHOULD BE >/=8. PUD V6.81 HAS RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI AT 4 INSTEAD OF 8. INCIDENT HAPPENED DURING USE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965073 ↗
• MalfunctionNov 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD EPICENTER¿ SINGLE USER SOFTWARE MISIDENTIFIED I FOR CEFEPIME, EVEN WITH NO MIC ANTIBIOTIC ON THE PANEL. IT WAS NOT CONFIRMED THAT REPEAT TESTS WERE PERFORMED, AND THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE CLINICIANS. THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6)TRIGGERED CREATING AN INTERPRETATION OF I FOR CEFEPIME, DESPITE THERE BEING NO MIC FOR THIS ANTIBIOTIC ON THE PANEL. SAMPLE (B)(4) (2 PANELS TESTED WITH SAME RESULT, SAME ORGANISM DESPITE BEING GIVEN DIFFERENT ISOLATE NUMBERS" WERE PATIENT SAMPLES INVOLVED? YES. IS A CONFIRMATORY TEST ALWAYS PERFORMED? NO. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? NO (ONLY IDENTIFIED AS HSL). WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759372 ↗
• MalfunctionOct 14, 2021False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD EPICENTER¿ SINGLE USER SOFTWARE PRODUCED A FALSE POSITIVE RESULT WHEN THE AZTREONAM SUSCEPTIBILITY TESTING FAILED ON THE P. AERUGINOSA ISOLATE DUE TO INCONSISTENT GROWTH PATTERNS. 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: "A PHOENIX PANEL TESTED WHERE THE AZTREONAM SUSCEPTIBILITY TESTING FAILED ON A P. AERUGINOSA ISOLATE (DUE TO INCONSISTENCIES IN THE GROWTH PATTERN). EVEN THOUGH THERE IS NO RESULT, RULE 982 HAS TRIGGERED AND REPORTED THE RESULT AS ¿I¿ FOR ¿SUSCEPTIBLE, INCREASED EXPOSURE¿. THIS RULE SHOULD ONLY TRIGGER WHEN AN MIC OF =<16 IS RETURNED, NOT WHERE THERE WAS NO MIC. IN THIS INSTANCE THE ORGANISM WAS RESISTANT TO AZTREONAM. THERE ARE OBVIOUS CONCERNS THAT THIS IS NOT LIMITED TO AZTREONAM AND PSEUDOMONAS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12633089 ↗
• MalfunctionApr 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE A DISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIENT REPORTS THAT THEY REGISTER A TYPE OF SAMPLE, BUT WHEN THE RESULT WILL BE RELEASED, THE TYPE OF SAMPLE WAS CHANGED TO BLOOD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753744 ↗
• MalfunctionMar 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE AN APPLICATION SPECIMEN MANAGEMENT ERROR WAS OBSERVED WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586567 ↗
• MalfunctionFeb 17, 2021Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD EPICENTER¿ SINGLE USER SOFTWARE THERE WAS MISSASSOCIATION OF 10 PATIENTS TO SPECIMENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11339524 ↗