BD BACTEC™ MGIT™ 960 SIRE Kit 245123Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 SIRE Kit, carton of 4 lyophilized drug vials, and 8 SIRE Supplements · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT 960 SIRE kit, used to test tuberculosis drug susceptibility, has 166 reports, with no deaths and no injuries. Most reports describe false resistant results, sometimes with no growth in the tube, and none list a patient symptom. No recalls name this device, and reports rose from 57 in the prior 12 months to 84 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 166
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 00382902451235), received between Mar 15, 2021 and Aug 19, 2026 — classified as 166 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (161 reports).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings161
- Contamination2
- Contamination of Device Ingredient or Reagent2
- Device Ingredient or Reagent Problem1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions166
Recent adverse event reports
The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported while using the BD BACTEC¿ MGIT¿ 960 SIRE Kit, one (1) Ethambutol patient culture tube had positive growth and appeared visibly turbid. In addition, a reconstituted Ethambutol tube was inoculated without bacteria and visibly demonstrated turbid growth. A microscopic examination of a smear prepared from the tube revealed numerous cocci and other indistinct cellular forms. No clear acid-fast bacilli (AFB) were observed. There were no health impact or consequences reported.This is report 3 of 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325246 ↗MalfunctionAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325244 ↗MalfunctionAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323587 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 19 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700781 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 39 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700642 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 42 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700638 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 38 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700636 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 32 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700635 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 41 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700633 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 40 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700632 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 37 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700630 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 23 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700629 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 33 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700623 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 31 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700618 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 29 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700617 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 28 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700616 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 30 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700614 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 18 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700606 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 25 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700605 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 20 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700601 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 7 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700595 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 26 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700590 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 10 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700589 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 24 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700588 ↗MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 27 OF 42.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700587 ↗
Other SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL devices
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page