BioFire® Blood Culture Identification 2 (BCID2) Panel RFIT-ASY-0147Recalls & reported problems

Summary

The FDA's MAUDE database contains 555 adverse event reports that list this exact device (DI 00815381020338), received between Apr 12, 2023 and Sep 29, 2026 — classified as 6 deaths, 17 injuries, 532 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (507 reports).

6 FDA recall records name this device's identifier, 4 still open.

1 other recall cover devices cleared under the same FDA submission (K193519, K243759); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 19, 2024Class IIOpen, Classified

   If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

   Z-2456-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 26, 2024Class IIOpen, Classified

   Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

   Z-1139-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 17, 2023Class IIOpen, Classified

   Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

   Z-0451-2024 · Root cause: Process control · Recall details · FDA record ↗

4. Feb 1, 2023Class IIOpen, Classified

   Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

   Z-1251-2023 · Root cause: Environmental control · Recall details · FDA record ↗

5. Oct 11, 2021Class IITerminated

   Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.

   Z-0312-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

6. May 10, 2021Class IITerminated

   Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

   Z-1903-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 555 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026False Negative Result

  Summary: The customer "[(b)(6), Poland]" reported a potential false negative CTX-M result on the BioFire BCID2 Panel after testing a patient sample. The customer reported that due to the BCID2 Panel result, the patient was indirectly impacted, specifically inadequate treatment, which might lead to serious injury if it were to recur. No patient harm was reported.The investigation concluded that the most likely cause for the potential false negative CTX-M result is due to sensitivity and specificity differences between the BCID2 Panel and comparator susceptibility testing methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931811 ↗
• InjurySep 28, 2026False Positive Result

  Summary: The customer ((b)(6) Japan) reported a potential false positive MREJ and mecA/C (Methicillin-resistant Staphylococcus aureus) result on the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel after testing a patient blood culture bottle sample. The customer reported that due to the BCID2 Panel result, the patient was indirectly impacted, specifically by inappropriate treatment, which might lead to serious injury if it were to recur. The customer stated that the patient was not harmed.BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917306 ↗
• InjurySep 10, 2026False Negative Result

  Summary: The customer (b)(6) reported potential false-negative Escherichia coli result on the BioFire Blood Culture Identification 2 (BCID2) Panel after testing a patient sample. Due to the BCID2 Panel results, the patient was indirectly impacted, specifically by a delay in treatment/care, which might lead to serious injury if it were to recur. No patient harm was reported. The investigation concluded that the most likely cause of the E. coli discrepant result was a strain variant with reduced reactivity to the BioFire BCID2 Panel E. coli assay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716398 ↗
• InjurySep 10, 2026False Negative Result

  Summary: The customer "[(b)(6), USA]" reported potential false-negative results on the BioFire Blood Culture Identification 2 (BCID2) Panel after testing patient samples. Due to the BCID2 Panel results, 2 of the 3 patients were indirectly impacted, specifically by a delay in care, which might lead to serious injury if it were to recur. 1 of the 3 patients was not reported to have been affected. No patient harm was reported. The customer stated that 2 of the 3 patients were affected, but did not specify which patients were impacted ((b)(6) male, 78-year-old male, or 80-year-old female). The following potential discrepant results were reported: Patient #1: false negative E. coli;Patient #2: false negative P. aeruginosa;Patient #3: false negative P. mirabilis. Please note two MDRs will be submitted, one for each affected patient. This MDR pertains to the second affected patient. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716392 ↗
• InjurySep 1, 2026False Negative Result; False Positive Result

  Summary:The customer (Indiana, USA) reported a potential false positive Haemophilus influenzae (H. influenzae) and Bacteroides fragilis (B. fragilis), and false negative Streptococcus spp. result on the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel after testing a patient blood culture sample. The customer reported that due to the BCID2 result, the patient was indirectly impacted, specifically by a delay in appropriate treatment for approximately two days, which might lead to serious injury if it were to recur. No patient harm was reported. The investigation concluded that the most likely cause of the false positive H. influenzae and B. fragilis results and false negative Streptococcus spp. results was sensitivity/specificity differences between the BIOFIRE BCID2 Panel and culture while testing polymicrobial samples.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542223 ↗
• InjuryAug 11, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216360 ↗
• InjuryAug 11, 2026False Positive Result

  (B)(6) ((b)(6)) reported potential false positive methicillin-resistant Staphylococcus aureus (MRSA) results on the BioFire® Blood Culture Identification 2 (BCID2) Panel after testing a patient blood culture sample. The customer reported that due to the BCID2 Panel result, that patient experienced indirect harm, specifically the patient was put on vancomycin and ceftriaxone, which might lead to serious injury if it were to recur. No patient harm was reported. The investigation determined that the most likely cause of the discrepant MRSA result was sensitivity/specificity differences between the BIOFIRE® BCID2 Panel and comparator phenotypic susceptibility methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206851 ↗
• InjuryAug 10, 2026False Positive Result

  (b)(6) reported a potential false positive vanA/B result on the BioFire® Blood Culture Identification 2 (BCID2) Panel after testing a patient blood culture sample. The customer reported that due to the BCID2 result, that patient experienced indirect harm, specifically the patient was taken off of vancomycin and was put on 6 weeks of IV Daptomycin and Ampicillin then moved to Linezolid, which might lead to serious injury if it were to recur. No patient harm was reported. The investigation determined that the most likely cause of the discrepant vanA/B results was sensitivity/specificity differences between the BIOFIRE® BCID2 Panel and comparator phenotypic susceptibility methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198045 ↗
• InjuryJul 29, 2026False Negative Result

  Hospital Descentralizado Guillermo Rawson (San Juan, Argentina) reported a potential false negative OXA-48 result on the BioFire® Blood Culture Identification 2 (BCID2) Panel after testing a patient sample. The customer reported that due to the BCID2 result, the patient experienced a delay in appropriate therapy and unnecessary imaging studies. The customer stated that the patient was not harmed.BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066961 ↗
• DeathMay 21, 2026False Negative Result

  SUMMARY: SAMODZIELNY PUBLICZNY SZPITAL [LUBLIN, POLAND] REPORTED A POTENTIAL FALSE NEGATIVE MRSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER MIXING THE CONTENT OF 4 BLOOD CULTURE BOTTLES. THE CUSTOMER REPORTED THAT DUE TO THE BCID2 RESULT, THE SELECTION OF ANTIMICROBIAL THERAPY FOR THE PATIENT WAS AFFECTED. THE PATIENT DIED ON (B)(6) 2026 AND THE CUSTOMER STATED THEY DID NOT KNOW IF THERE WAS A DIRECT IMPACT OF FALSE NEGATIVE RESULTS AND THE FOLLOWING TREATMENT PROCESS. AS MRSA WAS NOT DETECTED BY THE INITIAL BCID2 TEST AND WAS NOT COVERED BY EMPIRIC ANTIMICROBIAL THERAPY, BIOMÉRIEUX MEDICAL AFFAIRS DETERMINED THAT THE POSSIBILITY CANNOT BE EXCLUDED THAT THE BCID2 RESULT MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH DUE TO A DELAY IN APPROPRIATE THERAPY. THE INVESTIGATION CONCLUDED THAT THE CUSTOMER WAS POOLING ALL POSITIVE AEROBIC AND ANAEROBIC BLOOD CULTURE SAMPLES INTO A SINGLE ALIQUOT TO TEST ON THE BCID2 PANEL; THIS FALLS OUTSIDE OF THE INTENDED USE OF THE BCID2 PANEL AND IS CONSIDERED OFF-LABEL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247699 ↗
• DeathApr 21, 2026False Negative Result

  SUMMARY: THE CUSTOMER ((B)(6)) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS POSSIBLY IMPACTED BY THE BIOFIRE RESULTS. THE MISSED BCID2 PANEL DETECTION RESULTED IN A 24-HOUR DELAY IN STARTING PATHOGEN-DIRECTED EMPIRIC THERAPY. DURING THIS TIME, THE PATIENT CLINICALLY DECOMPENSATED AND WAS TRANSFERRED TO THE ICU. THE PATIENT EVENTUALLY EXPIRED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Sepsis

  MAUDE report 24946174 ↗
• MalfunctionDec 5, 2025False Positive Result; False Positive Result

  SUMMARY: PUUMALA ET AL. PUBLISHED A STUDY, "A RETROSPECTIVE EVALUATION OF THE BIOFIRE FILMARRAY BLOOD CULTURE IDENTIFICATION 2 PANEL FOR THE DETECTION OF PATHOGENIC YEASTS," WHICH DESCRIBES A POTENTIAL FALSE POSITIVE CANDIDA TROPICALIS DETECTION ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL DURING PATIENT TESTING. NO PATIENT IMPACT WAS DESCRIBED IN THE PUBLICATION. THE AUTHORS WERE USING BD BACTEC BLOOD CULTURE BOTTLES. THE INVESTIGATION CONCLUDED THAT A LIKELY CAUSE OF THE POTENTIAL FALSE-POSITIVE RESULT WAS THE PRESENCE OF NON-VIABLE NUCLEIC ACID IN BLOOD CULTURE MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729310 ↗
• MalfunctionNov 12, 2025False Positive Result; False Positive Result

  SUMMARY: FENLON ET AL. PUBLISHED A CASE STUDY, "MASQUERADING YEAST: A CASE REPORT OF LOMENTOSPORA PROLIFICANS FUNGEMIA WITH A DIAGNOSTIC TWIST¿ FROM THE UNIVERSITY OF UTAH HOSPITAL (SALT LAKE CITY, UTAH) WHICH DESCRIBES A POTENTIAL FALSE POSITIVE CANDIDA TROPICALIS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL DURING PATIENT TESTING. THE PUBLICATION DESCRIBED A MULTI-FACETED CLINICAL PRESENTATION AND CLINICAL COURSE, WHICH EVENTUALLY INCLUDED THE PATIENT'S DETERIORATION AND DEATH. PER BIOFIRE MEDICAL AFFAIRS, IT IS UNLIKELY THAT THE BIOFIRE BCID2 PANEL RESULTS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH; HOWEVER, A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE AUTHORS WERE USING BD BACTEC BLOOD CULTURE BOTTLES. IT IS LIKELY THAT THE CANDIDA TROPICALIS RESULT WAS DUE TO NON-VIABLE NUCLEIC ACID FRAGMENTS IN THE BLOOD CULTURE MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535109 ↗
• DeathSep 30, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING PATIENT BLOOD CULTURE SAMPLES. DUE TO THE BIOFIRE BCID2 PANEL RESULT (K. PNEUMONIAE 'DETECTED', E. FAECALIS 'NOT DETECTED'), THE PATIENT'S VANCOMYCIN TREATMENT WAS DISCONTINUED, AND TREATMENT WAS CHANGED TO CEFOTAXIME. THE CUSTOMER REPORTED THAT THE PATIENT DIED OF SEPSIS. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE E. FAECALIS RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE BIOFIRE BCID2 PANEL AND OTHER METHODS WITHIN POLYMICROBIAL BLOOD CULTURES.

  Patient problems: Sepsis

  MAUDE report 23187380 ↗
• MalfunctionJun 25, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF PATIENT CARE WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22330724 ↗
• MalfunctionJun 11, 2025False Positive Result; False Positive Result

  SUMMARY: HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22183838 ↗
• MalfunctionJun 11, 2025False Positive Result; False Positive Result

  SUMMARY: HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANTS. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22183837 ↗
• MalfunctionJun 11, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22183836 ↗
• MalfunctionJun 5, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL REPORTED POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING PATIENT BLOOD CULTURE SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151396 ↗
• MalfunctionJun 5, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151385 ↗
• MalfunctionMay 30, 2025False Positive Result; False Positive Result

  SUMMARY: HOSPITAL (B)(6) ((B)(6), CHILE) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22118591 ↗
• MalfunctionMay 30, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: Insufficient Information

  MAUDE report 22118590 ↗
• MalfunctionMay 21, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (SEOUL, SOUTH KOREA), REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067332 ↗
• MalfunctionMay 21, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6), REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067003 ↗
• MalfunctionMay 21, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)), REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067002 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193519, K243759. One submission often covers many models, so check the product and lot details in each record.

• Z-1158-2021 · Jan 26, 2021 · Terminated
  BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.