BD BBL™ Lowenstein-Jensen Medium Slants 220909Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30382902209097), received between Apr 12, 2021 and Jun 7, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. HAD VARIOUS PH VARIATIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALONG WITH GREETINGS, I WOULD LIKE THROUGH THIS MEDIUM TO EXPOSE THE SITUATION THAT OCCURRED WITH CULTURE MEDIA, WHICH, AS INDICATED IN THE ATTACHED INVOICE, WERE PURCHASED IN THE MONTH OF NOVEMBER OF THE YEAR 2022, FOR WHICH REASON WE RECENTLY OPENED THE REMAINING BOXES (4 BOXES) TO CARRY OUT CONTROL. OF QUALITY, AND WE FOUND THAT ALMOST ALL OF THE BOXES HAD PH VARIATIONS (SEE ATTACHED IMAGE, HERE YOU CAN SEE TUBES WITH PH VARIATIONS ON THE LEFT HAND SIDE AND NORMAL TUBES ON THE RIGHT HAND SIDE), OF THE 400 TUBES IT WAS POSSIBLE TO RESCUE 75. WE REVIEWED THE TRACEABILITY OF THE TEMPERATURES IN THE CABINET WHERE THE CULTURE MEDIA ARE STORED AND THERE HAVE BEEN NO VARIATIONS. THEREFORE, WE ASSOCIATE IT WITH MANUFACTURING QUALITY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083534 ↗
• MalfunctionAug 30, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. HAD CONTAMINATION. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "THE CLIENT REPORTS CONTAMINATION RESULTS IN QUALITY CONTROL SAMPLES OF STERILITY OF THE CULTURE MEDIUM. THERE ARE NO SAMPLES OF PATIENTS INVOLVED. A FOLLOW-UP WAS CARRIED OUT WITH THE CLIENT IN ORDER TO CLARIFY THAT IT IS A NEW QUALITY CONTROL TEST, BECAUSE THE PRODUCT WAS RECEIVED IN MAY AND THE INCUBATION WAS CARRIED OUT ACCORDING TO THE INSTRUCTIONS. MICROBIAL DEVELOPMENT IS DETECTED IN TWO BOXES OF LOWENSTEIN-JENSEN CULTURE MEDIUM CORRESPONDING TO THE LAST ORDER DELIVERED (MAY). THEY CORRESPOND TO LOT 1265556. A STERILITY CONTROL WAS CARRIED OUT AT THE MOMENT OF RECEIVING THEM ON 10 TUBES AT RANDOM, WITHOUT OBTAINING DEVELOPMENT AT THAT TIME, SO THEY MAY BE SLOW-GROWING GERMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322901 ↗
• MalfunctionAug 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER GROWTH FOUND IN AND AROUND 220909 LJ TUBE, BATCH 1322720. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GROWTH FOUND IN AND AROUND 220909 LJ TUBE, BATCH 1322720.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171818 ↗
• MalfunctionDec 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. TUBES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBIAL GROWTH IN CULTURE MEDIUM TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097136 ↗
• MalfunctionNov 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 3600 BD BBL¿ PREPARED LOWENSTEIN-JENSEN MEDIA TUBES FROM LOT 1154486, 1100 TUBES FROM LOT 1174674, AND 1000 TUBES FROM LOT 1196549 WERE CONTAMINATED WITH COLONIES ON THE LJ SLANTS AND HAD UNEVEN GRADIENTS OF COLOR IN THE AGAR. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COLONIES WERE SEEN ON THE LJ SLANTS AND UNEVEN GRADIENT IN COLOR OF THE AGAR WAS OBSERVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814190 ↗
• MalfunctionOct 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 22 TUBE LOWENSTEIN-JENSEN MED SL A 100 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE OBVIOUS COLONIES GROWTH ON THE SURFACE OF THE LJ AND ON THE SIDE OF THE REPLACEMENT LJS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674471 ↗
• MalfunctionOct 7, 2021Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION WAS DISCOVERED BEFORE USE WITH THE TUBE LOWENSTEIN-JENSEN MED SL A 100 EA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LJ (LOT: 1092598 AND 1147876) ARE MORE BLUE-ISH THAN USUAL. THERE SEEMED TO HAVE SOME SHEER LAYER OF YELLOWISH TRANSPARENT COLONIES AND SPOTS ON THE LJ SURFACES. THERE ARE SOME WHITE SPOTS ON THE INNER GLASS OF THE LJ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594323 ↗
• MalfunctionJul 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 17 BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HEREBY REPORT THAT TUBES WITH MICROBIAL GROWTH HAVE BEEN DETECTED AMONG THE CULTURE MEDIA RECEIVED A FEW WEEKS AGO. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249159 ↗
• MalfunctionJul 8, 2021Contamination; Contamination

  IT WAS REPORTED THAT DURING USE WITH BD BBL¿; LOWENSTEIN-JENSEN MEDIUM SLANTS 6 TUBES WERE CONTAMINATED AND GROWING MYCOBACTERIUM MUCOGENICUM. NEGATIVE CONTROL HAS BEEN INCUBATING AND RESULTS HAVE NOT BE YET BEEN REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING POSSIBLE CONTAMINATION WITH PRODUCT 220909, LOT 0218586. THEY HAVE SEEN 6 TUBES GROWING MYCOBACTERIUM MUCOGENICUM WHICH IS MUCH HIGHER THAN THEY WOULD NORMALLY SEE. THE ORGANISMS WERE ID¿D WITH BRUKER. TUBES ARE RECEIVED REFRIGERATED AND STORED REFRIGERATED ONCE RECEIVED. CUSTOMER STATES TUBES WERE INOCULATED OVER THE COURSE OF A FEW DAYS TOWARDS THE END OF APRIL, BEGINNING OF MAY, AND IS UNSURE IF THE SAME HOOD WAS USED WHEN INOCULATING THE TUBES EACH TIME. CUSTOMER STATES THEY HAVE A NEGATIVE CONTROL INCUBATING AND WILL CHECK TO SEE IF THERE IS ANY GROWTH AND GET BACK WITH THAT INFORMATION. CUSTOMER WANTS TO KNOW IF THERE HAVE BEEN ANY OTHER CASES OF THIS TYPE OF CONTAMINATION WE ARE AWARE OF AS THEY ARE TRYING TO INVESTIGATE WHAT IS GOING ON AT THEIR FACILITY. NO RESULTS HAVE BEEN REPORTED OUT AS CUSTOMER HAS SET TUBES ASIDE BECAUSE THEY FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135584 ↗
• MalfunctionApr 12, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 20 BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS THE PRODUCT BEEN USED FOR PATIENT TESTING AND WERE THERE ANY ADVERSE EFFECTS IF USED? NO. CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN PRODUCT 220909 LOT 0092841, TUBE LOWENSTEIN, JENSEN MED SL A. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING:  INITIATED COMPLAINT; REPORTEDLY CONTAMINATED UPON ARRIVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653783 ↗