BD Kiestra™ InoqulA+™ 447202Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00382904472023), received between Jan 25, 2019 and Mar 5, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (13 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-2438-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS PATIENT RESULTS DURING USE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524748 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS PATIENT RESULTS DURING USE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471643 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS RESULTS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926873 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING POTENTIAL INCORRECT RESULTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628035 ↗
• MalfunctionNov 15, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE BARCODA GAS SPRINGS ON THE BD KIESTRA INOQULA DID NOT HOLD THE HOOD UP. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693881 ↗
• MalfunctionNov 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD KIESTRA INOCULATION SYSTEM, THERE WAS POSSIBLE CONTAMINATION OF THE SLIDE PROCESSING MODULE WHICH LED TO A FALSE PATIENT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586987 ↗
• MalfunctionApr 9, 2024Structural Problem; Structural Problem

  IT WAS REPORTED WHEN USING THE BD KIESTRA INOQULA THE BARCODA PRINTER HOOD SPRING COULD NOT KEEP THE LID OPEN AND WOULD CLOSE ON ITS OWN. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069773 ↗
• MalfunctionFeb 16, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA DID NOT DISPENSE SAMPLE ON PLATES RESULTING IN NO GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722776 ↗
• MalfunctionFeb 5, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHEN USING THE BD KIESTRA INOQULA THERE WAS FALSE NEGATIVE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641224 ↗
• MalfunctionDec 6, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THERE WAS A FALSE NEGATIVE RESULT. NO PATIENT IMPACT OR CHANGE IN TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278464 ↗
• MalfunctionJul 7, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA OBTAINED A FALSE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RANDOM NO GROWING IN SOME INOCULATED DISHES. CAN YOU KINDLY CONFIRM IF THERE IS PATIENT SAMPLES WERE INVOLVED? YES THERE WERE PATIENT SAMPLES INVOLVED. I. DID THE COURSE OF TREATMENT CHANGE? IF YES, PROVIDE DETAILS. THE COSTUMER IS NOT AWARE OF THIS HAPPENING. THEY IDENTIFIED THAT THE PDV MIGHT BE FAILING BECAUSE THEY SAW SOME SAMPLES WHERE THE ABUNDANCE OF BACTERIA IN GRAM STAINED SLIDES DID NOT MATCH THE ABSENCE OF GROWTH IN THE OTHER PLATES FOR THAT PATIENT. BECAUSE THEY HAVE THE GRAM STAIN AS A DOUBLECHECK, THEY MANUALLY INOCULATED THE SAMPLES AGAIN FOR A SECOND TIME IN THE SAME KIND OF PLATES AND THERE WAS GROWTH. THE ONLY CHANGE FOR THIS SAMPLES WOULD HAVE BEEN A DELAY IN REPORTING RESULTS BACK. MORE SAMPLES WITHOUT GRAM STAIN MIGHT HAVE BEEN AFFECTED BUT THE COSTUMER WAS NOT AWARE OF IT. II. WERE THERE ERRONEOUS RESULTS? IF YES, PROVIDE DETAILS. AGAIN THE COSTUMER REALIZED IN THE SAMPLES WITH THE GRAM, AND DOESN¿T KNOW IF ANY FALSE NEGATIVE MIGHT HAVE GONE OUTIN SAMPLES WITHOUT GRAM. AS FAR AS WE KNOW, THERE WERE NO ERRONEOUS RESULTS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278430 ↗
• MalfunctionApr 4, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA INOQULA GAS SPRING ON SMALL INNER HOOD FOR BARCODA PRINTER BARELY HOLDING UP THE HOOD. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FSE NOTICED THE GAS SPRING FOR THE SMALL HOOD COVER OF THE BARCODA PRINTER IS BARELY HOLDING THE HOOD UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678744 ↗
• MalfunctionMar 8, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD KIESTRA INOQULA PDV SENSOR DIRTY COULD CAUSE POTENTIAL FALSE NEGATIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PDV SENSOR DIRTY AND NOT CLEANED AS PER USER MANUAL. CLEANING ALLOWS SENSOR TO OPERATE CORRECTLY. THERE WERE INSTANCES OBSERVED WERE THE INOQULA WAS "INOCULATING" SOME PLATES WHERE NO MICROORGANISM WAS GROWING. THE COSTUMER COULD SEE BACTERIA IN THE GRAM SLIDE FOR THEM AND IF THEY INOCULATED THE MICROORGANISM IN SEMIAUTOMATED MODE OR MANUALLY THERE WAS GROWTH. SO THOSE PLATES COULD BE SEEN AS NEGATIVE WHEN IN REALITY THEY WOULD BE FALSE NEGATIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504769 ↗
• MalfunctionJan 5, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA INOQULA GAS SPRINGS NEEDED TO BE REPLACED. LID WAS REPORTED TO HAVE FALLEN DOWN. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID THE BARCODA LID FALL DOWN OR SLAM? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109008 ↗
• MalfunctionNov 18, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA INOQULA LID NOT HOLDING UP PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS. WE NEED MORE INFO REGARDING THIS PR. DID THE LID FALL OFF? IF SO IT CHANGED REPORTABILITY. THE LID DID NOT FALL OFF, BUT THE GAS SPRING DOES NOT HOLD IT PROPERLY, HENCE THE CASE TO REPLACE THIS PARTS. THIS ISSUE WAS NOTICED DURING PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826423 ↗
• MalfunctionNov 15, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT BD KIESTRA INOQULA LID WON'T STAY UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPLACE GAS SPRINGS BARCODA HOOD - BARCODA LID WON'T STAY UP. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798282 ↗
• MalfunctionOct 18, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING THE BD KIESTRA INOQULA THE HOOD DOES NOT STAY IN THE UP POSITION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOOD OF THE BARCODA DOES NOT STAY IN THE UP POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626830 ↗
• MalfunctionOct 11, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT WHILE USING THE BD KIESTRA INOQULA THE COVER IS SLAMMING SHUT AND A TECH GOT HURT WHILE WORKING ON THE BARCODA. PER CUSTOMER THE LOCK IS MALFUNCTIONING AND WILL NOT STAY UP. THE TECH'S HEAD GOT HIT BY THE COVER AND THEY HAVE A BRUISE ON THEIR HEAD. UPON EVALUATION, NO MEDICINE OR PAIN MEDICATION WAS ADMINISTERED AND NOTHING WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE BARCODA COVER IS SLAMMING SHUT AND A TECH GOT HURT WHILE WORKING ON BARCODA. PER CUSTOMER THE LOCK MACANIZAN MULFUNCTIONING WILL NOT STAY UP. CUSTOMER WANTED TO HAVE FSE TAKE A LOOK AT IT BEFORE IT BECOMES PHYSICAL HAZARD. TECH'S HEAD GOT HIT BY THE COVER AND HAVE BRUISE ON HER/HIS HEAD. UPON EVALUATION, NO MEDICINE OR PAIN MEDICATION WAS ADMINISTERED AND NOTHING WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577847 ↗
• MalfunctionMay 20, 2022Structural Problem; Structural Problem

  IT WAS REPORTED WHILE TESTING WITH BD KIESTRA INOQULA THE BARCODA LID FELL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GAS HOOD SPRINGS BARCODA DEFECTIVE THE GAS SPRINGS DID NOT HOLD THE LID. BUT THE PROBLEM HAS BEEN FIXED. THE GAS SPRINGS HAVE BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459343 ↗
• MalfunctionApr 5, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA'S BARCODA HOOD GAS SPRING WAS NOT FUNCTIONING AND WOULD NOT HOLD UP THE LID. THIS IS A ONE TIME OCCURENCE REPORT. THIS DOES NOT RESULT IN FALSE RESULTS OR A SERIOUS INJURY, BUT THIS EVENT COULD LIKELY LEAD TO INJURY OR CRUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING MY LAST VISIT THE CUSTOMER ADDRESSED THAT THE BARCODA HOOD GAS SPRINGS DOES NOT LIFT OR HOLD PRESSURE ANYMORE." "DURING MY VISIT THE CUSTOMER ADDRESSED THAT THE GAS SPRINGS FOR THE BARCODA HOOD WEREN¿T HOLDING PRESSURE. I FUNCTIONED TESTED THE GAS SPRINGS AND CONCLUDED IT NEEDS REPLACEMENT. TO AVOID IMMINENT INJURIES I TOOK THE LIBERTY TO ORDER AND INSTALL NEW GAS SPRINGS. NO INJURIES WAS REPORTED BY THE CUSTOMER. BUT IT¿S A HAZARD THAT NEEDS TO BE CORRECTED IMMEDIATELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017862 ↗
• MalfunctionMar 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BD KIESTRA¿ INOQULA+¿ HAD AN ISSUE WITH THE BARCODA LID FALLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DOOR ABOVE PRINTER FALLS DOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971685 ↗
• MalfunctionMar 29, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PRINTER LID ON BD KIESTRA¿ INOQULA+¿ WAS FALLING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE COVER ON THE PRINTER FALLS OFF SPORADICALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934915 ↗
• MalfunctionMar 24, 2022Structural Problem; Structural Problem

  IT WAS REPORTED BD (B)(4) HAD AN ISSUE WITH THE BARCODA LID FALLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTS THE COVER FOR THE BARCODA PRINTER SLAMS SHUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895693 ↗
• MalfunctionJan 24, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA FALSE POSITIVE RESULTS WERE OBTAINED 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: " SAMPLE WITH 4 DISHES PROCESSED REPROCESSED AFTER A 2ND SAMPLE WITH 3 DISHES AND CONTAMINATED BY 2ND SAMPLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13335108 ↗
• MalfunctionDec 17, 2021Device Fell; Device Fell

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THE GAS SPRINGS ON THE BARCODA PRINTER FAILED TO KEEP THE HOOD/LID OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BOTH GAS SPRINGS ON HOOD OF THE BARCODA PRINTER NOT HOLDING THE HOOD. CUSTOMER PROBLEM: FSE WAS ON-SITE FOR ((B)(4)), AND NOTICED THE BOTH GAS SPRING WHICH HOLD THE HOOD OF THE BARCODA PRINTER IS NOT FIRMLY SECURING THE HOOD. THEREFORE, THE HOOD WOULD NOT STAY OPEN WHEN LAB TECH OPEN TO CLEAR PLATES AND LABELS. IT WOULD CONSIDER NOT SAFE FOR LAB TECH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026376 ↗