FilmArray® BCID Panel RFIT-ASY-0127Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815381020093), received between Jul 18, 2019 and Jul 18, 2019 — classified as 1 death.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJul 18, 2019False Negative Result; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) HOSPITAL ((B)(6)) REPORTED DISCREPANT SERRATIA MARCESCENS AND PSEUDOMONAS AERUGINOSA RESULTS ON THE FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL AFTER TESTING A PATIENT SAMPLE. THE PATIENT ULTIMATELY EXPIRED. IT IS UNKNOWN IF THE FILMARRAY BCID PANEL RESULTS AFFECTED PATIENT CARE OR PATIENT OUTCOME. 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 A KNOWN CROSS-REACTIVITY BETWEEN THE S. MARCESCENS ASSAY AND A P. AERUGINOSA STRAIN WITH REDUCED REACTIVITY FOR THE P. AERUGINOSA ASSAY (A SIMILAR STRAIN WAS TESTED DURING PERFORMANCE EVALUATIONS AND IS DETAILED IN THE IFU).

  Patient problems: Death

  MAUDE report 8804603 ↗