VIDAS® B·R·A·H·M·S PCT ™ 30450-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 03573026223601), received between Feb 7, 2019 and Aug 28, 2025 — classified as 1 injury, 125 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (105 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. Nov 9, 2022Class IIOpen, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0868-2023 · Root cause: Storage · Recall details · FDA record ↗

2. Sep 22, 2021Class IIOpen, Classified

   bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

   Z-0428-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025High Test Results; High Test Results

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B¿R¿A¿H¿M¿S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917919 ↗
• InjuryDec 27, 2023False Positive Result; False Positive Result

  ON 20-DEC-2023, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF POTENTIAL FALSE-POSITIVE RESULTS LEADING TO INCORRECT PATIENT TREATMENT WHEN USING VIDAS BRAHMS PROCALCITONIN 60T (REF. (B)(4), LOT 1010079250, EXPIRY DATE: 20-NOV-2024). THE CUSTOMER TESTED A PEDIATRIC PATIENT SAMPLE. THE CUSTOMER REPORTED THAT WITH ONE STRIP WHERE IT APPEARS THE SAMPLE WAS NOT TRANSFERRED TO THE APPROPRIATE WELL. THE SAMPLE WAS INITIALLY RESULTED AS POSITIVE, BUT UPON RE-RUNNING IT WAS NEGATIVE. HERE THE RESULT OBTAINED AND THE CORRECTION AFTER RETESTING: 29.17 NG/ML THAT WAS CORRECTED TO 0.70 NG/ML CUSTOMER CONTINUED TO RUN SAMPLES ON THE B SIDE OF THE MINIVIDAS INSTRUMENT, VERIFIED ALL STRIPS TO CONFIRM THAT SAMPLE TRANSFER OCCURRED. THE CUSTOMER COMPLETED A QUALITY CONTROL VIDAS (QCV) TEST AT THE REQUEST OF BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE). QCV PASSED WITH NO ERRORS, INDICATING THE INSTRUMENT WAS WORKING CORRECTLY. THE CUSTOMER NOTED THEY WILL CONTINUE RUNNING QCV WEEKLY. DISCUSSION WITH THE CUSTOMER INDICATED THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS DUE TO CLOTTED / LIPEMIC SAMPLES. IT IS WRITTEN IN THE INSTRUCTIONS FOR USE THAT "IT IS RECOMMENDED NOT TO USE SAMPLES THAT ARE HEMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396654 ↗
• MalfunctionJan 20, 2023Low Test Results; Low Test Results

  ON (B)(6) 2023, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING UNDERESTIMATED RESULT WHEN TESTING PATIENT SAMPLE WITH VIDAS BRAHMS PROCALCITONIN 60T (REF: (B)(4), BATCH NUMBER: 1009431890, EXPIRY DATE: 15-NOV-2023). THE CUSTOMER PERFORMED TEST ON PATIENT SAMPLES WITH VIDAS®BRAHMS PROCALCITONIN 60T (REF: (B)(4), LOT#: 1009431890). HE FOUND FOAM/BUBBLES ON ONE OF THE REAGENT STRIPS WHEN RUNNING. THE RESULTS WERE UNDERESTIMATED AS FOLLOW: FIRST TEST: 0,28. THE CUSTOMER RERAN TEST WITHIN AN HOUR, AND HE OBTAINED THE FOLLOWING RESULT: SECOND TEST: 0,95. THE UNDERESTIMATED RESULT WAS SENT TO THE PHYSICIAN BEFORE THE CUSTOMER REALIZED THE ISSUE. THEY CORRECTED THE RESULT AND REPORTED IT TO THE PHYSICIAN. THE CUSTOMER STATED THAT THE CHANGE IN RESULT DID NOT MODIFY THE TREATMENT. PATIENT WAS NOT HARMED. THE QCV WAS DONE AND CORRECT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215854 ↗
• MalfunctionSep 29, 2022Low Test Results; Low Test Results

  ON (B)(6) 2022, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING UNDERESTIMATED RESULTS WHEN TESTING EXTERNAL QUALITY CONTROL WITH VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1009182760, EXPIRY DATE: 05-JUL-2023). THE CUSTOMER PARTICIPATED TO THE LINEARITY/ CALIBRATION K841M-5 LOT 06790 FROM AUDIT. THE CUSTOMER TESTED THE DIFFERENT EXTERNAL QUALITY CONTROL ON (B)(6) 2022 AND OBTAINED UNDERESTIMATED RESULT FOR LEVELS B, C, D AND E COMPARED TO PEERS, AS FOLLOWS: LEVEL B: PEER MEAN = 44.006 NG/L (N=12) ¿ USER MEAN = 38.8 NG/L. LEVEL C: PEER MEAN = 92.705 NG/L (N=12) ¿ USER MEAN =77.36 NG/L. LEVEL D: PEER MEAN = 151.022 NG/L (N=12) ¿ USER MEAN = 122.8 NG/L. LEVEL E: PEER MEAN = 187.518 NG/L (N=8) ¿ USER MEAN = 144.84 NG/L. TO BE NOTED THAT THE CALIBRATION OF THE KIT VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1009182760) WAS PERFORMED ON THE (B)(6) 2022 AND WAS VALID. AS THERE IS NO PATIENT ASSOCIATED WITH THIS EXTERNAL QUALITY CONTROL, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503046 ↗
• MalfunctionSep 1, 2022High Test Results; High Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING NON REPRODUCIBLE OVERESTIMATED RESULTS WHEN TESTING QC SAMPLES USING VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH 1009137690, EXPIRY DATE 07-JUN-2023). RESULTS ON (B)(6) 2022 FOR SAMPLES LN41: LEVEL 1: 0.34 THEN 0.34. LEVEL 2: 11.93 THEN 11.97. LEVEL 3: 35.22 THEN 34.05. LEVEL 4: 62.79 THEN 55.70. LEVEL 5: 139.60 THEN 124.78. LEVEL 6: THE FIRST RESULTS WERE > 200 NG/ML ON BOTH RUNS. THE UPPER END OF THE MEASUREMENT RANGE IS 200NG/ML. THEREFORE, THE CUSTOMER PERFORMED 1:10 DILUTION AND THEN DIVIDED BY 2. THE FINAL RESULTS ARE 253.19 AND 251.52 OBTAINED ON (B)(6) 2022. THE ALLOWABLE ERROR RATE IS 12.5% AND IT IS EXCEEDED FOR SAMPLES LEVEL 2, LEVEL 4, 5 AND 6 COMPARED TO THE PEER MEAN. THE CUSTOMER MENTIONED THAT THERE WAS NO DELAY IN REPORTING. AS THE SAMPLES ARE QC SAMPLES, THERE IS NO PATIENT IMPACT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342601 ↗
• MalfunctionJul 1, 2022High Test Results; High Test Results

  ON (B)(6) 2022, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING OUT OF RANGE HIGH RESULT WHEN TESTING EXTERNAL QUALITY CONTROL WITH VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1008987800, EXPIRY DATE: 19-MAR-2023). THE EXTERNAL QUALITY CONTROL IS L1 FROM AUDIT MICRO CONTROL (LOT 06799) AND THE EXPECTED RANGES ESTABLISHED BY THE CUSTOMER ARE: MEAN: 0.50 [0.44-0.56]. DURING MAY-2022, THE CUSTOMER OBTAINED OUT RANGE TOO HIGH RESULTS AT DIFFERENT MOMENT: 03-MAY: 0.58, 04-MAY: 0.58, 07-MAY: 0.78, 07-MAY: 0.58, 24-MAY: 0.57, 25-MAY: 0.57, 28-MAY: 0.58, 29 MAY: 0.57, 29-MAY: 0.57, TO BE NOTED THAT THE CALIBRATION OF VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1008987800,) PERFORMED ON 20-APR-2022 AND 05-MAY-2022 WERE VALID. AS THIS WAS AN EXTERNAL QUALITY CONTROL, NO PATIENT SAMPLE WAS INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885935 ↗
• MalfunctionApr 27, 2022High Test Results; High Test Results

  ISSUE DESCRIPTION. ON (B)(6) 2022, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING AN OVERESTIMATED RESULT WHEN TESTING WITH VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1009004570, EXPIRY DATE: (28-MAR-2023) ON ONE EXTERNAL QUALITY CONTROL, CAP SURVEY PCT 01. THE QC SAMPLE IS A QC FROM EXTERNAL QUALITY ASSESSMENT CAP SURVEY, IDENTIFIED AS PCT 01. ON (B)(6) 2022, THE CUSTOMER TESTED THREE DIFFERENT SAMPLES AND OBTAINED THE FOLLOWING RESULTS: PCT-01: CUSTOMER'S RESULT=11.41 NG/ML FOR MEAN 8.640 NG/ML (366 LABS) AND RANGE [6.98-10.30] TOO HIGH. PCT-02: CUSTOMER'S RESULT=2.69 NG/ML FOR MEAN 2.726 NG/ML (377 LABS) AND RANGE [2.20-3.25]. OK PCT-03: CUSTOMER'S RESULT=0.61 NG/ML FOR MEAN 0.546 NG/ML (372 LABS) AND RANGE [0.40-0.69]. OK ON (B)(6) 2022, THE CUSTOMER TESTED AGAIN THE QC SAMPLE ID PCT-01: CUSTOMER'S RESULT=10.90 NG/ML FOR RANGE [6.98-10.30]. THE RESULT WAS STILL OVERESTIMATED. CALIBRATIONS WERE DONE ON (B)(6) 2022 AND (B)(6) 2022; THEY WERE VALID. THERE IS NO POTENTIAL PATIENT¿S IMPACT DUE TO THIS ISSUE, AS IT IS IN A CONTEXT OF EXTERNAL QUALITY CONTROL. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14217180 ↗
• MalfunctionDec 22, 2021Failure to Calibrate; Failure to Calibrate

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING A CALIBRATION ISSUE WHEN USING VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER 1008952560, EXPIRY DATE 26-FEB-2023). IT WAS REPORTED THAT RFU VALUES WERE HIGH. AT THE TIME OF THIS ASSESSMENT, IT IS NOT KNOWN WHETHER THE HIGH RFV CONCERNED THE STANDARD OR CONTROLS. THE CUSTOMER MENTIONED A DELAY IN REPORTING RESULTS OF ONE DAY. THE NUMBER OF INVOLVED PATIENTS IS NOT KNOWN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061720 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057754 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057753 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057750 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057715 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057712 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057710 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057707 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057706 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057683 ↗
• MalfunctionDec 21, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057673 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048932 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048895 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048849 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048813 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK,TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATIENTS WITH SUSPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048752 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048738 ↗
• MalfunctionDec 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048515 ↗