FilmArray® BCID Panel RFIT-ASY-0126Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815381020086), received between Mar 12, 2019 and Dec 14, 2021 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “False Positive Result” (3 reports).

2 FDA recall records 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 20, 2021Class IITerminated

   Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

   Z-2245-2021 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 14, 2018Class IITerminated

   There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.

   Z-1513-2018 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathDec 14, 2021False Negative Result; False Negative Result

  HOLD GN 12-15SUMMARY: A PUBLICATION BY RULE ET AL. TITLED "DIAGNOSTIC ACCURACY OF THE BIOFIRE FILMARRAY BLOOD CULTURE IDENTIFICATION PANEL WHEN USED IN CRITICALLY ILL PATIENTS WITH SEPSIS" CONTAINED INFORMATION REGARDING POTENTIAL FALSE NEGATIVE ENTEROBACTERALES AND KLEBSIELLA PNEUMONIAE DETECTIONS ON THE FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL AFTER TESTING A SAMPLE FROM A (B)(6), FEMALE PATIENT. DUE TO THE FILMARRAY BCID PANEL RESULT, THE PATIENT'S ANTIBIOTIC THERAPY WAS DELAYED FOR 43.25 HOURS. WHILE INVESTIGATING THIS RESULT, BIOFIRE BECAME AWARE THAT THE PATIENT ULTIMATELY DIED, AND IT WAS UNKNOWN TO THE AUTHOR IF THE FILMARRAY BCID PANEL CONTRIBUTED TO THE PATIENT'S DEATH. BASED ON THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THAT THE CUSTOMER WAS NOT INTERPRETING THE RESULTS OF THE FILMARRAY BCID PANEL IN CONJUNCTION WITH THE GRAM STAIN RESULTS AS IS INTENDED. A LIKELY CAUSE FOR THE K. PNEUMONIAE AND ENTEROBACTERALES DISCREPANCIES IS SAMPLE-HANDLING ERROR. REFERENCE: RULE R, PARUK F, BECKER P, ET AL. DIAGNOSTIC ACCURACY OF THE BIOFIRE FILMARRAY BLOOD CULTURE IDENTIFICATION PANEL WHEN USED IN CRITICALLY ILL PATIENTS WITH SEPSIS. J MICROBIOL METHO

  Patient problems: Insufficient Information

  MAUDE report 13006510 ↗
• InjuryMay 21, 2020False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL AND MEDICAL CENTER ((B)(6)) REPORTED DISCREPANT MECA RESULTS ON THE FILMARRAY® BLOOD CULTURE IDENTIFICATION (BCID) PANEL AFTER TESTING A SAMPLE FROM A (B)(6)-YEAR-OLD, FEMALE PATIENT. DUE TO THE FILMARRAY BCID PANEL RESULTS, THE PATIENT WAS TREATED WITH VANCOMYCIN FOR 6 WEEKS. LATER IN THE COURSE OF THERAPY THE PATIENT EXPERIENCED A PERMANENT KIDNEY FUNCTION IMPAIRMENT THAT WAS CAUSED IN PART BY THE TREATMENT OF VANCOMYCIN. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE SYSTEM WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE MECA DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY BCID PANEL AND COMPARATOR METHODS WITH A POLYMICROBIAL SPECIMEN.

  Patient problems: Renal Failure

  MAUDE report 10080024 ↗
• DeathApr 18, 2019False Positive Result; False Positive Result

  (B)(6) REPORTED A DISCREPANT (B)(6) RESULT ON THE FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL AFTER TESTING A BLOOD SAMPLE FROM A (B)(6) YEAR OLD, MALE PATIENT. DUE TO THE FILMARRAY BCID PANEL RESULT, THE CUSTOMER REPORTED THAT TREATMENT WAS ALTERED AND THERE WAS POTENTIAL HARM TO THE PATIENT. ULTIMATELY, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY (AKI) AND EXPIRED ON (B)(6) 2019. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE SYSTEM WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THIS DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY BCID PANEL, STANDARD CULTURE, AND AST METHODS.

  Patient problems: Death; Renal Disease, End Stage

  MAUDE report 8529831 ↗
• InjuryMar 12, 2019False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) REPORTED A DISCREPANT MECA RESULT ON THE FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL AFTER TESTING A BLOOD SAMPLE FROM A (B)(6) YEAR OLD, IMMUNOCOMPROMISED, MALE PATIENT. DUE TO THE FILMARRAY BCID RESULT, THE CUSTOMER REPORTED THAT THE PATIENT WAS GIVEN UNNECESSARY TREATMENT FOR SEVERAL DAYS. THE CUSTOMER ALSO REPORTED THAT THE UNNECESSARY TREATMENT MAY HAVE CAUSED HARM TO THE PATIENT. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION CONCLUDED THE DISCREPANCY WAS MOST LIKELY CAUSED BY SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY BCID PANEL AND COMPARATOR METHODS, POSSIBLY IN COMBINATION WITH A SAMPLE CONTAINED A HETEROGENOUS POPULATION OF RESISTANT AND SUSCEPTIBLE STAPHYLOCOCCI.

  Patient problems: Renal Failure

  MAUDE report 8414780 ↗