BD Kiestra™ InoqulA+™ TLA 447213Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00382904472139), received between May 1, 2019 and May 14, 2026 — classified as 15 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (96 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 26, 2019Class IITerminated

   An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

   Z-2439-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA HAS BEEN FOUND PRODUCING INCORRECT RESULTS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172962 ↗
• MalfunctionSep 4, 2024Fire; Fire

  IT WAS REPORTED WHILE USING THE BD KIESTRA INOQULA TLA, THE PRINTER WAS FOUND WITH A FLAME COMING OUT OF IT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PRINTER CONNECTED TO WORKBENCH 2.4 SUDDENLY HAD A FLAME COMING OUT OF IT. THE FIRE ORIGINATED FROM THE POWER CORD. THE FIRE DIED OUT OF ITS OWN AND DID NOT CAUSE ANY DAMAGE OR INJURIES, EXCEPT TO THE PRINTER ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137754 ↗
• MalfunctionJun 7, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING USE WITH THE BD KIESTRA¿ INOQULA+¿ TLA, THE BARCODA HOOD FELL. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484643 ↗
• MalfunctionAug 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA, THERE WAS MISASSOCIATION OF ONE ACCESSION NUMBER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INOQULA SCANNING ASCESSION NUMBER INCORRECTLY. SCANNING (B)(6). THERE WERE NO ADVERSE EFFECTS OR RESULTS FROM THE MISS SCANNING. THE OPERATOR WAS ABLE TO SCAN THE SAMPLES MANUALLY AND PREVENT THE SAMPLE FROM BEING PROCESSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476505 ↗
• MalfunctionJun 26, 2023Patient Data Problem; Patient Data Problem

  IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA, A SPECIMEN WAS SYNCED TO THE INCORRECT PATIENT. THERE WAS ONE OCCURRENCE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A TECH WRONGLY SYNCED A SPECIMEN TO DIFFERENT PATIENT FROM THE CERNER. CUSTOMER SAID SHE ENTERED AN ACC# IN READING ¿ HIT ENTER LIKE NORMAL. SHE CLEARED OUT THE CERNER MRE SCREEN, UNCLICKED THE SCREEN SYNC, BUT DIDN¿T DO ANYTHING DIFFERENT IN RB. SHE NAVIGATED TO BATCH REPORTING AND NOTICED THAT THE ACC# THAT WAS PREVIOUSLY UP, DID NOT GO AWAY IN THE TOP RIGHT CORNER. ESCALATING TO SEE IF THIS ACC# BEING IN THE TOP RIGHT CORNER WHILE THE BATCH REPORTING SCREEN IS OPENED AFFECTED CULTURE MB230067983. AUDIT LOG SHOW A STOOL CULTURE (NOT INTENDED FOR BATCH REPORTING) BEING RELEASED AS A BATCH REPORT."

  Patient problems: Insufficient Information

  MAUDE report 17204942 ↗
• MalfunctionJun 5, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA¿ INOQULA+¿ TLA COVER SPRING IS DEFECTIVE ON ONE SIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE SPRING ON THE BARCODE HOOD IS LEAKING ON ONE SIDE COVER SPRING IS DEFECTIVE ON ONE SIDE, COVER SPRING NEEDS REPLACING, NO SPARE IN ENSURE, BAR IS IN PRODUCTION WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057093 ↗
• MalfunctionApr 7, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD KIESTRA¿ INOQULA+¿ TLA MACHINE ERROR CAUSE PATIENTS TO BE RETESTED DUE TO POSSIBLE DISCREPANCY IN RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHNOLOGIST WAS LOOKING AT THE INOQULA WHILE IT WAS INOCULATING A BI-PLATE. INSTEAD OF DISPENSING AN INOCULUM ON EACH SIDE OF THE BI-PLATE, THE INOQULA DISPENSED THE SAMPLE TWICE ON THE SAME SIDE. THE TWO BEADS WERE DELIVERED ON EACH SIDE AND THE STREAKING HAPPENED AS EXPECTED EVEN THOUGH ONLY ONE SIDE OF THE BI-PLATE CONTAINED SAMPLE INOCULUM. ALL THAT WITHOUT GIVING AN ERROR OR ALARM. ONLY FEW PATIENTS WERE RE-TESTED BUT NO COMPARISON WAS MADE TO IDENTIFY IF THERE WAS A DISCREPANCY WITH PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704558 ↗
• MalfunctionJan 28, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA¿ INOQULA+¿ TLA REAR HOOD GAS SPRINGS ARE WEAK. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REAR HOOD GAS SPRINGS NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261228 ↗
• MalfunctionNov 23, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING THE BD KIESTRA¿ INOQULA+¿ TLA THAT THE BARCODA HOOD WAS FALLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPLACE BARCODA HOOD GAS SPRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859668 ↗
• MalfunctionSep 29, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA THE BARCODA HOOD WOULD NOT STAY OPEN. THE GAS SPRINGS NEED TO BE REPLACED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GAS SPRINGS BARCODA HOOD NEEDS TO BE REPLACED, HOOD DOES NOT STAY OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506218 ↗
• InjuryJul 15, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA TLA- BARCODA LID CAME DOWN ON TECH FINGER. TECHNICIAN REPORTS THAT A LAB TECH HAD THE BARCODA LID COME DOWN ON THEIR FINGER. THE TECH WENT TO THE EMERGENCY ROOM AND HAD X-RAYS. NO BROKEN BONE FOUND. NO BLOOD REPORTED, TECH HAS A SMALL BRUISE, A BAND-AID WAS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033486 ↗
• MalfunctionJul 8, 2022Structural Problem; Structural Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD KIESTRA¿ INOQULA+¿ TLA GAS SPRINGS NEEDED TO BE REPLACED. MINOR INJURY WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GAS SPRINGS WOULD HOLD THE LID UP AS LONG AS IT WAS OPEN ALL THE WAY. IF THE LID WAS NOT OPENED PAST THE HALF WAY POINT IT WOULD FALL ON ITS OWN. THE USER THAT HAD THE LID FALL ON HER HAND TOLD ME THE LID WAS NOT OPENED ALL THE WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961815 ↗
• MalfunctionJun 24, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA THE BARCODA LID FELL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT HOOD GAS SPRINGS NEED REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808398 ↗
• MalfunctionFeb 28, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA PRODUCED FALSE POSITIVES ON TWO CULTURES PROCESSED THROUGH FA MODE, WITH ONE SAMPLE SHOWING 4+ GROWTH ON CNA, AND THE OTHER SHOWING 4+ GROWTH ON CHOCOLATE. HOWEVER, NO OTHER DISHES INOCULATED WITH THE SAMPLE SHOWED GROWTH. GRAM STAINS WERE DONE, PRODUCING NOS THE FIRST TIME, AND HEAVY GROWTH OF GNB THE NEXT. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED ERRONEOUS RESULTS ON TWO CULTURES THAT WERE PROCESSED THROUGH FA MODE ON THE INOQULA. ON BOTH SAMPLES, THERE WAS 4+ GROWTH ON CNA BUT NO GROWTH ON ANY OF THE OTHER DISHES THAT WERE INOCULATED WITH THE SAMPLE. SAMPLES WERE: (B)(6)." "CORRECTION: ON SAMPLE (B)(6) THERE WAS 4+ GROWTH ON CNA. ON SAMPLE (B)(6) THERE WAS 4+ GROWTH ON CHOCOLATE." "THIS PAST WEEKEND, WE HAD A CULTURE THAT ONLY GREW RARE GNB ON ONE OF THE PLATES. WHEN WE RESET UP THE CULTURE, IS WAS HEAVY GROWTH OF GNB. THE GRAM STAIN ALSO WAS NOS THE FIRST TIME. RESET UP OF THE GRAM STAIN WAS GNB. THE SLIDE APPEARS TO HAVE BEEN MADE IN THE FA MODE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620672 ↗
• MalfunctionFeb 25, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH THE BD KIESTRA¿ INOQULA+¿ TLA, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT A NEW ORGANISM IS BEING INTRODUCED IN THE BLOOD CULTURE. GRAM NEGATIVE RODS APPEARING ON BLOOD CULTURE WHEN IT SHOULD NOT BE. PATIENT RESULTS ARE INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13607733 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT WHILE USING THE LID FELL. THERE WAS NO INDICATION OF SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11368887 ↗
• MalfunctionJul 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING A BD KIESTRA¿ INOQULA TLA¿ TO PROCESS PATIENT SAMPLES A FAILURE TO INOCULATE SPECIMEN PLATES OCCURRED FOR 6 SAMPLES. THE LABORATORY INITIALLY INTERPRETED THE UN-INOCULATED PLATES AS NEGATIVE, AND REPORTED RESULTS AS SUCH. UPON RETESTING THE SAMPLES MANUALLY THE LABORATORY CONFIRMED THE CORRECT GROWTH RESULTS WERE OBTAINED. THE ISSUE RESULTED IN A 2 DAY DELAY FOR THE GROWTH IDENTIFICATION AND CORRECTED LAB REPORTS. NO ADVERSE MEDICAL IMPACT WAS REPORTED WITH REGARDS TO PATIENTS DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228220 ↗
• InjuryNov 1, 2019Difficult to Open or Close

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA, THE CUSTOMER WAS HAVING ISSUES WITH THE COVER OF THE BARCODA PRINTER AND SUSTAINED AN INJURY. THE COVER HAD A PROBLEM WITH THE GAS SPRINGS CAUSING IT TO NOT STAY OPEN PROPERLY, HITTING A LAB STAFF EMPLOYEE ON THE HEAD. THERE WAS NO BLEEDING OR BLOOD EXPOSURE. THE LAB STAFF WENT TO THE EMERGENCY WARD AND IT WAS DETERMINED THEY HAD A CONCUSSION. THE STAFF MEMBER WAS ON SICK LEAVE FOR SEVERAL DAYS, AND HAS NOW RETURNED TO WORK.

  Patient problems: Concussion; Head Injury; Injury

  MAUDE report 9266940 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936547 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936537 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936536 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936533 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936523 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION 20.3. DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936522 ↗
• MalfunctionAug 27, 2019Nonstandard Device; Data Problem

  IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA AN ANOMALY IS PRESENT IN INOQULA/ INOQULA+ SOFTWARE VERSION (B)(4). DURING THE INVESTIGATION INTO THIS ISSUE, THROUGH AUTOMATED LOG-FILE ANALYSIS MIS-ASSOCIATED PLATES/SPECIMENS WERE DISCOVERED. CUSTOMERS HAVE BEEN INFORMED ABOUT THE EVENTS, INCLUDING IDS AND ACCESSION IDS THAT WERE MIS-ASSOCIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936353 ↗