BACT/ALERT® SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03573026595746), received between Nov 14, 2017 and Feb 13, 2023 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Contamination” (21 reports).

1 other recall cover devices cleared under the same FDA submission (K021123); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023False Positive Result; False Positive Result

  AS PART OF A STUDY CONDUCTED ON POSITIVE RATE IN HIS LABORATORY, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT SN: B)(4) - (REF: (B)(4), LOT: 0001058472) THE CUSTOMER NOTED THAT BASED ON THE FALSE POSITIVE RESULTS PATIENTS WERE KEPT LONGER AND FLOWN OUT TO OTHER HOSPITALS. THE CUSTOMER ALSO CONFIRMED THAT ANTIBIOTICS WERE PRESCRIBED BASED ON THE FALSE POSITIVE RESULTS. THE CUSTOMER MENTIONS THAT THESE FALSE RESULTS HAS LED TO PATIENTS BEING KEPT LONGER OR FLOWN OUT. THE CUSTOMER ALSO CONFIRMED THAT THE PHYSICIAN HAD PRESCRIBED ANTIBIOTICS TO THE PATIENTS BASED ON THE FALSE POSITIVE RESULTS. AT THE TIME OF THE ASSESSMENT, THE CUSTOMER HAS NOT CONFIRMED IF THE FALSE POSITIVE RESULT IS A CLINICAL FALSE POSITIVE OR IF THEY ARE RELATED TO PROBABLE CONTAMINANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16365847 ↗
• MalfunctionAug 27, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® SN CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING POSSIBLE CLINICAL FALSE POSITIVE RESULTS (FALSE POSITIVE BOTTLE) FOR THREE (3) DIFFERENT PATIENTS IN ASSOCIATION WITH THE BACT/ALERT® SN (PLASTIC) (REF 259790, LOT 0001056942). THE CUSTOMER INFORMED BIOMÉRIEUX THAT THREE BOTTLES HAD TESTED POSITIVE AND CANDIDA GLABRATA WAS RECOVERED FROM THE BOTTLES. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE MATE BOTTLES (I.E. SA BOTTLES) FOR EACH PATIENT. FOR TWO OF THE PATIENTS, THE MATE BOTTLES WERE ALSO POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. THE THIRD PATIENT'S MATE BOTTLE WAS POSITIVE FOR A GRAM NEGATIVE ROD, AND CANDIDA GLABRATA WAS NOT RECOVERED. SAMPLES WERE RE-COLLECTED FOR EACH OF THE THREE PATIENTS. FOR ONE PATIENT, ONE BOTTLE FROM THE NEW SET OF SAMPLES WAS POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. FOR THE OTHER TWO PATIENTS, ALL BOTTLES FROM THE ADDITIONAL SAMPLES WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377410 ↗
• MalfunctionAug 27, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® SN CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING POSSIBLE CLINICAL FALSE POSITIVE RESULTS (FALSE POSITIVE BOTTLE) FOR THREE (3) DIFFERENT PATIENTS IN ASSOCIATION WITH THE BACT/ALERT® SN ((B)(4)) (REF 259790, LOT 0001056942). THE CUSTOMER INFORMED BIOMÉRIEUX THAT THREE BOTTLES HAD TESTED POSITIVE AND CANDIDA GLABRATA WAS RECOVERED FROM THE BOTTLES. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE MATE BOTTLES (I.E. SA BOTTLES) FOR EACH PATIENT. FOR TWO OF THE PATIENTS, THE MATE BOTTLES WERE ALSO POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. THE THIRD PATIENT'S MATE BOTTLE WAS POSITIVE FOR A GRAM NEGATIVE ROD, AND CANDIDA GLABRATA WAS NOT RECOVERED. SAMPLES WERE RE-COLLECTED FOR EACH OF THE THREE PATIENTS. FOR ONE PATIENT, ONE BOTTLE FROM THE NEW SET OF SAMPLES WAS POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. FOR THE OTHER TWO PATIENTS, ALL BOTTLES FROM THE ADDITIONAL SAMPLES WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377397 ↗
• MalfunctionAug 27, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® SN CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING POSSIBLE CLINICAL FALSE POSITIVE RESULTS (FALSE POSITIVE BOTTLE) FOR THREE (3) DIFFERENT PATIENTS IN ASSOCIATION WITH THE BACT/ALERT® SN (PLASTIC) (REF (B)(4), LOT 0001056942). THE CUSTOMER INFORMED BIOMÉRIEUX THAT THREE BOTTLES HAD TESTED POSITIVE AND CANDIDA GLABRATA WAS RECOVERED FROM THE BOTTLES. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE MATE BOTTLES (I.E. SA BOTTLES) FOR EACH PATIENT. FOR TWO OF THE PATIENTS, THE MATE BOTTLES WERE ALSO POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. THE THIRD PATIENT'S MATE BOTTLE WAS POSITIVE FOR A GRAM NEGATIVE ROD, AND CANDIDA GLABRATA WAS NOT RECOVERED. SAMPLES WERE RE-COLLECTED FOR EACH OF THE THREE PATIENTS. FOR ONE PATIENT, ONE BOTTLE FROM THE NEW SET OF SAMPLES WAS POSITIVE AND CANDIDA GLABRATA WAS RECOVERED. FOR THE OTHER TWO PATIENTS, ALL BOTTLES FROM THE ADDITIONAL SAMPLES WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377395 ↗
• MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A CRACKED INOCULATED BACT/ALERT® SN CULTURE BOTTLE (REF. 259790, LOT 0001056564) INSIDE THEIR BACT/ALERT® 3D INSTRUMENT. THE BOTTLE FLAGGED POSITIVE, THE EMPLOYEE NOTICED BLOOD INSIDE THE BOTTLE'S CELL, AND THEN OBSERVED A CRACK ON THE BOTTOM OF THE BOTTLE AFTER REMOVING FROM THE BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER CONFIRMED THEY RECEIVED THE INOCULATED BLOOD CULTURE BOTTLE FROM ANOTHER HOSPITAL, AND DID NOT KNOW HOW THE BOTTLE WAS TRANSPORTED OR IF THE STAFF COLLECTING THE SAMPLES INSPECTED THE BOTTLE PRIOR TO SAMPLE COLLECTION. THERE WAS NO STATEMENT FROM THE CUSTOMER REGARDING BOTTLE INSPECTION PRIOR TO LOADING INTO THE INSTRUMENT. THE CUSTOMER CONFIRMED THERE WAS NO BLOOD EXPOSURE TO ANY EMPLOYEE; PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN WHEN HANDLING THE LEAKING CULTURE BOTTLE AND WHEN PERFORMING THEIR DECONTAMINATION PROCEDURE. THE BROKEN BACT/ALERT® SN CULTURE BOTTLE HAD AN ASSOCIATED BACT/ALERT® SA CULTURE BOTTLE THAT FLAGGED POSITIVE FOR AEROCOCCUS URINAE. THE CUSTOMER STATED THE CRACKED BOTTLE DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT¿S STATE OF HEALTH. THE CUSTOMER ALSO CONFIRMED THE EMPLOYEE WORE PPE WHEN HAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931445 ↗
• MalfunctionApr 29, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF POTENTIAL BOTTLE CONTAMINATION WITH CLOSTRIDIUM PERFRINGES IN ASSOCIATION WITH THE BACT/ALERT® SN CULTURE BOTTLE (REF. 259790, LOT 0001055672) WHEN TESTING PATIENT BLOOD CULTURE. THE CUSTOMER STATED FOUR (4) BLOOD CULTURE SETS WERE COLLECTED IN A MULTI SURGICAL UNIT AND CONFIRMED THE BOTTLES WERE INSPECTED PRIOR TO USE. ONE BOTTLE FLAGGED POSITIVE, THE SUBCULTURE IDENTIFIED CLOSTRIDIUM PERFRINGES. THE TEST METHOD USED TO IDENTIFY THE ORGANISM WAS NOT PROVIDED. BIOMERIEUX CUSTOMER SERVICE ASKED THE CUSTOMER TO CONFIRM IF THE PATIENTS HAD ANY KNOWN GASTROINTESTINAL ISSUES AS CLOSTRIDIUM PERFRINGES IS FOUND IN NORMAL GUT FLORA. THE CUSTOMER CONFIRMED THE PATIENT DID NOT HAVE A HISTORY OF GASTROINTESTINAL ISSUES. THE CLOSTRIDIUM PERFRINGES WAS REPORTED TO THE TREATING PHYSICIAN; IT WAS DETERMINED THAT THIS RESULT WAS A CONTAMINANT BASED ON THE PATIENT¿S MEDICAL HISTORY AND THE NEGATIVE RESULTS FOR ALL OF THE OTHER SEVEN BOTTLES. THERE IS NO ADVERSE PATIENT IMPACT; THE TREATING PHYSICIAN DETERMINED CLOSTRIDIUM PERFRINGES RESULT WAS A CONTAMINANT AND NOT A TRUE RESULT. THE PATIENT WAS DIAGNOSED WITH COMMUNITY-ACQUIRED PNEUMONIA AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749812 ↗
• MalfunctionApr 1, 2021Material Integrity Problem; Material Integrity Problem

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMERIEUX OBSERVING BLOOD SPLATTER INSIDE OF THEIR VIRTUO® INSTRUMENT (REF. 1712) AND BLOOD LEAKAGE AND BUBBLES FROM BACT/ALERT® SN CULTURE BOTTLE (REF. 259790, LOT 0001055870). THE CUSTOMER STATED THEY NOTICED BLOOD LEAKAGE AND BUBBLES COMING FROM A POSITIVE BACT/ALERT® SN CULTURE BOTTLE SEPTUM DURING TRANSPORT TO THE BOTTLE PROCESSING AREA. IT WAS CONFIRMED BLOOD WAS VENTING FROM THE SEPTUM AREA OF THE BOTTLE AND THE BOTTLE WAS NOT CRACKED OR BROKEN. IT WAS ALSO CONFIRMED THE BOTTLE WAS NOT OVERFILLED. THE CUSTOMER THEN NOTICED SPLASHED BLOOD IN THE INSIDE OF THEIR VIRTUO® INSTRUMENT WHEN CORRECTING A ROBOT JAM. IT IS UNKNOWN IF THE BLOOD SPLATTER INSIDE THE INSTRUMENT WAS FROM THE VENTING BOTTLE OR FROM ANOTHER BOTTLE. THE CUSTOMER CONFIRMED THE EMPLOYEE WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) DURING BOTTLE TRANSPORT AND THAT THERE WAS NO BLOOD EXPOSURE TO ANY EMPLOYEE. THE CUSTOMER CONFIRMED THE CONTAMINATED AREAS WERE CLEANED FOLLOWING THEIR DECONTAMINATION PROCEDURE. BIOMERIEUX CUSTOMER SERVICE REVIEWED PICTURES PROVIDED BY THE CUSTOMER AND FOUND A BULGE AT THE SEPTUM INDICATING INCREASED GAS PRESSURE INSIDE THE BOTTLE. REVIEW OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604516 ↗
• MalfunctionMar 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING RECOVERY ISSUES (NEGATIVE RESULTS) IN ASSOCIATION WITH THE BACT/ALERT® SN BOTTLE (REF 259790). THE CUSTOMER ALSO REPORTED THIS ISSUE TO THE CHINA COMPETENT AUTHORITY (NMPA). THE INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THAT THE CUSTOMER IS EXPERIENCING ISSUES WITH THE BACT/ALERT SN BOTTLES BECAUSE THE BOTTLES DO NOT CONTAIN RESIN AND CANNOT ABSORB ANTIBIOTICS. THE CUSTOMER ALSO STATES THAT CLINICAL PATIENTS HAVE OFTEN TAKEN ANTIBIOTICS OUTSIDE THE HOSPITAL OR OTHER DEPARTMENTS, RESULTING IN THE POSITIVE RATE OF THE BOTTLE TO BE LOW. THE "PROCEDURAL NOTES AND PRECAUTIONS" SECTION IN THE PACKAGE INSERT FOR THE BACT/ALERT® SN BOTTLES INCLUDES THE FOLLOWING: "OBTAIN BLOOD SAMPLES PRIOR TO INITIATING ANTIBIOTIC THERAPY. IF THIS IS NOT POSSIBLE, DRAW BLOOD IMMEDIATELY BEFORE ADMINISTERING THE NEXT ANTIBIOTIC DOSE." THE "LIMITATIONS OF THE TEST" SECTION OF THE PACKAGE INSERT INCLUDES THE FOLLOWING STATEMENT: "ON RARE OCCASIONS ORGANISMS MAY BE ENCOUNTERED THAT GROW IN THE BACT/ALERT® SN CULTURE BOTTLE GROWTH MEDIA BUT DO NOT PRODUCE SUFFICIENT CARBON DIOXIDE TO BE DETERMINED POSITIVE. A FACTOR THAT MAY LEAD TO THIS SITUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569145 ↗
• MalfunctionSep 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A BACILLUS CONTAMINATION ASSOCIATION WITH THE BACT/ALERT® SN CULTURE BOTTLE (REF. 259790, LOT 0001055178) TESTING PATIENT BLOOD CULTURE. THE BACILLUS CONTAMINATION WAS OBSERVED AT TWO SEPARATE HOSPITALS. THE CUSTOMER STATED THE BLOOD CULTURE WAS PERFORMED BY BOTH PHLEBOTOMISTS AND NURSING STAFF. THE CUSTOMER ALSO CONFIRMED THE TIME TO DETECTION OCCURRED AFTER TWENTY-FOUR (24) HOURS OF INCUBATION. THE CUSTOMER ALSO OBSERVED BACILLUS CONTAMINATION USING THE BACT/ALERT® PF PLUS CULTURE BOTTLE (REF. 410853, LOT 0004055448). REFER TO (B)(4). BIOMÉRIEUX CUSTOMER SERVICE REQUESTED DETAIL REGARDING THE BLOOD CULTURE COLLECTION PROCEDURE USED, VENIPUNCTURE SITES, STORAGE CONDITIONS OF THE BACT/ALERT® PF PLUS CULTURE BOTTLES PRIOR TO USE, AND IF ANY BOTTLES APPEARED CONTAMINATED PRIOR TO USE. FEEDBACK HAS NOT YET BEEN PROVIDED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE CONTAMINATION RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10510034 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF POSITIVE BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW (B)(6). SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE (B)(6). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07; LOT # 1053290, EXP. 2020-03-12; LOT # 1052766, EXP. 2020-01-01; LOT # 1053418, EXP. 2020-04-01; LOT # 1052142, EXP. 2019-10-03; LOT # 1052254, EXP. 2019-10-17. BA

  Patient problems: Misdiagnosis

  MAUDE report 8903772 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF POSITIVE BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED POSITIVE AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07. LOT # 1053290, EXP. 2020-03-12. LOT # 1052766, EXP. 2020-01-01. LOT # 1053418, EXP. 2

  Patient problems: Misdiagnosis

  MAUDE report 8903753 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903734 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF POSITIVE BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW (B)(6). SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE (B)(6). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07 LOT # 1053290, EXP. 2020-03-12 LOT # 1052766, EXP. 2020-01-01 LOT # 1053418, EXP. 2020-04-01 LOT # 1052142, EXP. 2019-10-03 LOT # 1052254, EXP. 2019-10-17 BACT/ALE

  Patient problems: Misdiagnosis

  MAUDE report 8903729 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903717 ↗
• MalfunctionAug 8, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8876615 ↗
• MalfunctionAug 8, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8876613 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864498 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864491 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864486 ↗
• MalfunctionJan 10, 2019False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF ISSUES WITH GROWTH OF CLOSTRIDIUM SPOROGENES ATCC 19404 IN BACT/ALERT® SN BLOOD CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTING HAVING A PROCEDURE FOR ACCEPTING THESE BOTTLES FOR USE IN ESTABLISHING THE STERILITY OF STEM CELLS USED FOR TRANSPLANTATION AND THIS PROCEDURE FOLLOWS GUIDELINES SET OUT IN THE EUROPEAN PHARMACOPIAE GUIDELINES 2011 VOLUME V METHOD 2.6.27. ONE (1) OF THE ORGANISMS RECOMMENDED BY THIS METHOD IS CLOSTRIDIUM SPOROGENES ATCC 19404. WHEN THE CUSTOMER PERFORMED THE BATCH ACCEPTANCE INITIALLY ON LOT NO: 1051021 THIS ORGANISM FAILED TO GROW WHEN THE BOTTLES WERE INOCULATED WITH A CONCENTRATION OF ORGANISM AT 10-5. A COLUMBIA BLOOD AGAR PLATE INOCULATED WITH THE SAME SUSPENSION GREW 45 COLONIES ON OVERNIGHT INCUBATION IN ANAEROBIC CONDITIONS. A SUSPENSION OF BACTEROIDES FRAGILIS ATCC 25285 AT A CONCENTRATION OF 10-6 GREW SUCCESSFULLY IN THE BOTTLES. ALTHOUGH NOT NORMALLY USED IN THE PROCEDURE THE CUSTOMER USED A STRAIN OF CLOSTRIDIUM PERFRINGENS ATCC 19401 AND THIS SUCCESSFULLY GREW IN THE BOTTLES. THE CUSTOMER ATTEMPTED THE PROCEDURE AGAIN USING A NEW LOT NUMBER OF BOTTLES (1051203) BUT AGAIN THE CLOSTRIDIUM SPO

  Patient problems: No Patient Involvement

  MAUDE report 8236192 ↗
• MalfunctionDec 26, 2018False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF GROWTH PERFORMANCE ISSUE ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED DURING THE BATCH ACCEPTANCE PROCEDURE USED TO ESTABLISH THE STERILITY OF STEM CELLS USED FOR TRANSPLANT PER THE EUROPEAN PHARMACOPEIA GUIDELINES 2011 VOLUME V METHOD 2.6.27 ONE OF THE ORGANISMS RECOMMENDED BY THIS METHOD, CLOSTRIDIUM SPOROGENES ATCC 19404, FAILED TO GROW IN AN INOCULATED BOTTLE WITH CONCENTRATION OF ORGANISM AT 10-5. A COLUMBIA BLOOD AGER PLATE INOCULATED WITH THE SAME SUSPENSION GREW 45 COLONIES ON OVERNIGHT INCUBATION IN ANAEROBIC CONDITIONS. A SUSPENSION OF BACTEROIDES FRAGILIS ATCC 25285 AT A CONCENTRATION OF 10-6 GREW SUCCESSFULLY IN THE BOTTLES. ALTHOUGH NOT NORMALLY USED IN THE PROCEDURE, THE CUSTOMER USED A STRAIN OF CLOSTRIDIUM PERFRINGENS ATCC 19401 WHICH SUCCESSFULLY GREW IN THE BOTTLES. THE CUSTOMER ATTEMPTED THE PROCEDURE AGAIN USING A NEW LOT NUMBER OF BOTTLES (1051203) BUT AGAIN THE CLOSTRIDIUM SPOROGENES ATCC 19404 FAILED TO GROW AT A CONCENTRATION OF 10-5 AND ALSO AT A CONCENTRATION OF 10-4. A NEW STRAIN OF ORGANISM FROM A LYOPHILIZED CULTURE (RECONSTITUTED PER MANUFACTURING GUIDELINES) WAS ALS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8195991 ↗
• MalfunctionOct 5, 2018Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DELAYED RESULTS DUE TO CONTAMINATION ASSOCIATED WITH BACT/ALERT® SN BLOOD CULTURE BOTTLE (REFERENCE (B)(4)). THE CUSTOMER REPORTED SEVEN (7) PATIENTS SAMPLES THAT WITH BACILLUS CONTAMINATION IN THE BLOOD CULTURE BOTTLES. DUE TO THE CONTAMINATION THERE WAS A DELAY IN REPORTING PATIENT RESULTS BETWEEN 0.5 TO 3.5DAYS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939938 ↗
• MalfunctionOct 5, 2018Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DELAYED RESULTS DUE TO CONTAMINATION ASSOCIATED WITH BACT/ALERT® SN BLOOD CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED SEVEN (7) PATIENTS SAMPLES THAT WITH BACILLUS CONTAMINATION IN THE BLOOD CULTURE BOTTLES. DUE TO THE CONTAMINATION, THERE WAS A DELAY IN REPORTING PATIENT RESULTS BETWEEN 0.5 TO 3.5DAYS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939936 ↗
• MalfunctionOct 5, 2018Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DELAYED RESULTS DUE TO CONTAMINATION ASSOCIATED WITH BACT/ALERT® SN BLOOD CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED SEVEN (7) PATIENTS SAMPLES THAT WITH BACILLUS CONTAMINATION IN THE BLOOD CULTURE BOTTLES. DUE TO THE CONTAMINATION THERE WAS A DELAY IN REPORTING PATIENT RESULTS BETWEEN 0.5 TO 3.5 DAYS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939933 ↗
• MalfunctionOct 5, 2018Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DELAYED RESULTS DUE TO CONTAMINATION ASSOCIATED WITH BACT/ALERT® SN BLOOD CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED SEVEN (7) PATIENTS SAMPLES THAT WITH BACILLUS CONTAMINATION IN THE BLOOD CULTURE BOTTLES. DUE TO THE CONTAMINATION THERE WAS A DELAY IN REPORTING PATIENT RESULTS BETWEEN 0.5 TO 3.5 DAYS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021123. One submission often covers many models, so check the product and lot details in each record.

• Z-0243-2007 · Aug 17, 2006 · Terminated
  bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790