BD Synapsys™ Informatics Solution 444150Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00382904441500), received between Jun 9, 2021 and Feb 16, 2026 — classified as 1 injury, 80 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (73 reports).

5 FDA recall records name this device's identifier, 3 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-0591-2025 · Root cause: Software design · FDA record ↗

2. Sep 12, 2024Open, Classified

   Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

   Z-0026-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Jun 8, 2023Open, Classified

   There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

   Z-2099-2023 · Root cause: Software design · FDA record ↗

4. Mar 9, 2022Terminated

   When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

   Z-1018-2022 · Root cause: Under Investigation by firm · FDA record ↗

5. Feb 21, 2019Terminated

   BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

   Z-1051-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Computer Software Problem

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, A PATIENT'S SPECIMEN WORKUP DISH COULD NOT BE FOUND IN THE SYSTEM. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349787 ↗
• MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION RULE 984 DID NOT TRIGGER DESPITE MEETING THE REQUIRED CRITERIA. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646721 ↗
• MalfunctionSep 18, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, THERE WERE MISSING CONTAINER IDS FOR ONE ACCESSION NUMBER. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083148 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895592 ↗
• MalfunctionAug 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, TESTS OF THE PREVIOUS ISOLATE ARE BEING ADDITIONALLY ORDERED TO THE NEXT NEW ISOLATE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686512 ↗
• MalfunctionJun 27, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, RULE BD10021 WAS MARKING CULTURES WITHOUT AN ORGANISM ID AS CONTAMINANTS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345140 ↗
• MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION BACTEC BOTTLE STATUSES WERE NOT BEING UPDATED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292473 ↗
• MalfunctionJun 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE INTEGRATING BD SYNAPSYS¿ INFORMATICS SOLUTION ONTO THE SITE, SEVERAL SPECIMENS DID NOT HAVE AN ASSOCIATED PATIENT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179569 ↗
• MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION THE VIAL STATUSES WERE NOT UPDATING ACCORDING TO THE INSTRUMENT'S VIAL RESULTS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953433 ↗
• MalfunctionMay 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, A SAMPLE WAS MISSING IN SYNAPSYS RESULTS FOR 5 DAYS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945815 ↗
• MalfunctionMay 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION VIAL STATUS AND RESULTS AREN'T UPDATING ACCORDING TO THE INSTRUMENTS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945321 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ AN UNSPECIFIED NUMBER OF PARTIAL ACCESSIONS WERE ASSOCIATED TO THE SEQUENCE NUMBERS, DESPITE THE FULL ACCESSION NUMBER PRESENTED IN THE INSTRUMENT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925741 ↗
• MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, THE INCORRECT ACCESSION WAS DISPLAYED WITH THE INCORRECT TEST AND TUBE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950714 ↗
• MalfunctionJun 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE REPORT PRESENTED INCORRECT RESULTS. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524629 ↗
• MalfunctionMay 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSES¿ THE PLATE IMAGES SHOWN FOR ONE PATIENT SAMPLE NUMBER APPEARED UNDER A DIFFERENT PATIENT SAMPLE NUMBER. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310065 ↗
• MalfunctionApr 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿, THERE WAS MISASSOCIATION SEEN WITH MULTIPLE SAMPLES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116002 ↗
• MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING USING BD SYNAPSYS¿ THERE WAS AN APPLICATION ERROR THAT CAUSED CHANGES TO THE BLOOD CULTURE PROTOCOL TIME. THIS IS A REPORT OF ONE OCCURRENCE, AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652783 ↗
• MalfunctionNov 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD SYNAPSYS THAT THERE WAS INCORRECT DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYN : NUMBERS IN SYNAPSYS NOT MATCHING WITH MOLIS. IMPACT: NO ADVERSE IMPACT ON HEALTHCARE PROFESSIONALS AND PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18134634 ↗
• MalfunctionOct 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THAT THERE WAS AN APPLICATION ERROR THAT AFFECTS PATIENTS SAMPLES, THAT DID NOT ALERT THE USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REACHED OUT STATING 5 AM TRIGGER TIME WAS NOT WORKING FOR NO GROWTH MESSAGES TO THE LIS FOR THE 5 DAY FINAL MESSAGE. THE CUSTOMER STATED THE 4 PM TRIGGER TIME WAS THE ONLY TIME THEY SAY THE 5 DAY FINAL MESSAGES AND THE TRIGGER TIMES WERE FINE FOR THE PRELIMINARY MESSAGES. THE CUSTOMER NORMALLY PULLS BOTTLES BETWEEN 6 AM AND 4 PM, THIS MEANS THAT THOSE WOULD BE TRIGGERED AT THE 4 PM TIMEFRAME SINCE THAT IN THE NEXT TRIGGER TIME AND UNLIKE THE PRELIMINARY MESSAGES, THEY DO NOT REQUIRE THE CULTURE TO BE COMPLETED LIKE THE 5 DAY FINAL RULE THAT IS SET FOR THIS INSTALL. I DID CONFIRM THAT THERE WERE INSTANCES WHERE RESULTS WERE TRIGGERED AT 5 AM WHEN BOTTLES WERE PULLED BETWEEN 4 PM AND 5 AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913683 ↗
• MalfunctionSep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THERE WAS MISASSOCIATION OF ONE SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING DESCRIPTION OF LIS TRANSMISSION HX FROM ONE OF THE TECHNOLOGISTS "THE TECH SKIPPED A CULTURE (70OB23677545) AND WHEN THE NEW PATIENT POPULATED ON THE KIESTRA SCREEN (10OB23682401), IT DIDN'T POPULATE ON THE CERNER SCREEN. THE TECH THEN RESULTED THE CULTURE AND THE RESULTS WENT TO THE PREVIOUS CULTURE WHICH WAS SKIPPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835521 ↗
• MalfunctionSep 26, 2023Non Reproducible Results; Non Reproducible Results

  PLEASE CLARIFY - IS THE CUSTOMER ALLEGING THAT SYN DID NOT SEND ANY RESULTS TO THE LIS OR THAT THE SYN SYSTEM SENT INCORRECT RESULTS? IF THE CUSTOMER IS STATING THAT INCORRECT RESULTS WERE TRANSMITTED, PLEASE CLARIFY WHAT IMPACT THIS HAD TO PATIENTS (IF ANY). RESPONSE:IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THAT THERE WAS INCORRECT DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WED AUG 30 14:18:48 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MISMATCH BETWEEN 1 RESULT IN SYNAPSYS AND WHAT LIS CALLED OUT. ROOTCAUSE UNCLEAR YET. SAMPLE NR (B)(6). IN SYNAPSYS THE RESULT IS (PARTIALLY POSITIVE), IN SCREEN IT THE FOLLOWING RESULT IS STATED: CLIENT ALREADY INFORMED; DESTROY ZAS. [SIC] THIS DOES NOT MATCH. NONE OF BOTH. THEIR LIS (SCREEN IT) WAS NOT ABLE TO RECEIVE PARTIAL RESULTS FROM SYNAPSYS, AND THE CUSTOMER WANTED TO SEE IF THE ISSUE WAS ON BD SIDE OR ON LIS SIDE. IT WAS CONFIRMED THE ISSUE IS ON LIS SIDE. NO IMPACT ON PATIENTS. WED (B)(6) 14:18:48 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MISMATCH BETWE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821301 ↗
• MalfunctionSep 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THAT THERE WAS INCORRECT DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYNAPSYS ANONYMOUS DOUBLE ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821285 ↗
• MalfunctionAug 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿, THERE IS AN INCREASED POTENTIAL FOR MISASSOCIATION OF AN UNSPECIFIED NUMBER OF VIALS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOMETIMES NO ASSOCIATION OF ACCESSION NO TO THE BOTTLES (ORPHAN VIAL WORKFLOW TROUGH LIS)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484126 ↗
• MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿, SAMPLE 23270212201 APPEARED AS A DOUBLE RECORD. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER EMAILED SAYING THAT SAMPLE 23270212201 AFTER OPENING IT IN SYNAPSYS WAS SHOWING NO PLATES PICTURES (EMPTY). AFTER TROUBLESHOOTING REMOTELY, IT WAS FOUND THAT THE SAMPLE HAS TWO RECORDS IN SYNAPSYS. SO, SEARCHING THE NUMBER GIVES THE SAME SAMPLE TWICE AND ONE OF THEM HAS THE PLATES IMAGES AND THE OTHER DOESN'T."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358147 ↗
• MalfunctionJul 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD SYNAPSYS¿, PATIENT DATA WAS ASSOCIATED TO THE INCORRECT PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MRSA RESULT ASSOCIATED WITH INCORRECT LAB NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289185 ↗