FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00815381020109), received between Jul 11, 2019 and Sep 23, 2026 — classified as 2 deaths, 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (22 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K140407, K143005, K160459, K230404, K242367); 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. May 16, 2024Class IIOpen, Classified

   Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

   Z-2514-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 26, 2024Class IIOpen, Classified

   Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

   Z-1140-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Nov 27, 2023Class IIOpen, Classified

   A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

   Z-0703-2024 · Root cause: Process control · Recall details · FDA record ↗

4. Apr 25, 2023Class IIOpen, Classified

   The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

   Z-2588-2023 · Root cause: Software design · Recall details · FDA record ↗

5. Mar 8, 2023Class IIOpen, Classified

   Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

   Z-1392-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-1253-2023 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026False Positive Result

  Summary: The customer "[(b)(6) Canada]" reported a potential false positive Yersinia enterocolitica result on the FilmArray Gastrointestinal (GI) Panel after testing a patient's stool sample. The customer reported that due to the GI Panel result, the patient was indirectly impacted, specifically unnecessary treatment, which might lead to serious injury if it were to recur. No patient harm was reported. Based on the information provided, the investigation concluded that the most likely cause for the discrepant result was low-level organism/nucleic acid contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866621 ↗
• InjurySep 10, 2026False Positive Result

  Summary: The customer (Aviles, Spain) reported a potential false positive Giardia lamblia (G. lamblia) result on the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel after testing a patient stool sample. The customer reported that due to the GI Panel result, the patient was indirectly impacted, specifically by inappropriate treatment, which might lead to serious injury if it were to recur. No patient harm was reported.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 50714064 ↗
• DeathSep 17, 2025False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. 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: Insufficient Information; Sepsis

  MAUDE report 23078175 ↗
• MalfunctionJun 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED TWO POTENTIAL FALSE POSITIVE VIBRIO AND VIBRIO CHOLERA RESULTS ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE GI PANEL RESULTS AS IT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635411 ↗
• MalfunctionJun 18, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, IT IS UNKNOWN IF THE PATIENT WAS IMPACTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19563844 ↗
• MalfunctionJun 11, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERA RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, IT IS UNKNOWN IF THE PATIENT WAS IMPACTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERA RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510011 ↗
• MalfunctionJun 5, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE CUSTOMER STATED THAT THE PATIENT WAS POSSIBLY PLACED INTO CONTACT PRECAUTIONS DUE TO THE DISCREPANCY. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19472701 ↗
• MalfunctionApr 29, 2024False Positive Result; False Positive Result

  SUMMARY: CLÍNICA INDISA (PROVIDENCIA, CHILE) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE PATIENT IMPACT DUE TO THE BIOFIRE GI PANEL IS UNKNOWN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19205605 ↗
• MalfunctionApr 3, 2024False Positive Result; False Positive Result

  SUMMARY: LANCET LAB (BLOEMFONTEIN, SOUTH AFRICA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE TREATMENT AND ALSO HAD TO BE ISOLATED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19037445 ↗
• MalfunctionApr 3, 2024False Positive Result; False Positive Result

  SUMMARY: LANCET LAB (BLOEMFONTEIN, SOUTH AFRICA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, THE PATIENT RECEIVED INAPPROPRIATE TREATMENT AND HAD TO BE ISOLATED. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19037422 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT AS THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001118 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT AS THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001004 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) MEDICAL CENTER ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19000844 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: HAMPTON VA MEDICAL CENTER (HAMPTON, VA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19000623 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER STATED THAT THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000527 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) MEDICAL CENTER REPORTED TWO POTENTIAL FALSE POSITIVE VIBRIO RESULTS ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. DUE TO THE BIOFIRE GI PANEL RESULT, THE CUSTOMER STATED THAT THERE WAS A SMALL DELAY IN REPORTING RESULTS. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000502 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000492 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: HAMPTON VA MEDICAL CENTER (HAMPTON, VA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19000488 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: HAMPTON VA MEDICAL CENTER (HAMPTON, VA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: Insufficient Information

  MAUDE report 19000357 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) MEDICAL CENTER (KANSAS CITY, MO) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER STATED THAT THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000205 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (MARIETTA, OH) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. DUE TO THE BIOFIRE GI PANEL RESULT, THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE TREATMENT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000190 ↗
• InjurySep 12, 2019False Positive Result

  POSSIBLE FALSE POSITIVE VIBRIO CHOLERA DETECTED AND REPORTED. PT WAS TRANSFERRED TO A NEW FACILITY AND ALSO PLACED ON TETRACYCLINE FOR VIBRIO INFECTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9028916 ↗
• InjurySep 12, 2019Incorrect, Inadequate or Imprecise Result or Readings

  DISCREPANCIES BETWEEN TESTING FOR BIOFIRE GI PANEL. INITIAL SPECIMEN WAS SUBMITTED AND TESTED. THE FOLLOWING ORGANISMS WERE DETECTED: CAMPYLOBACTER, ENTEROAGGREGATIVE E. COLI (EAEC), SHIGELLA / ENTEROINVASIVE E. COLI (EIEC), AND NOROVIRUS GI / GII. IT WAS DISCOVERED THE FOLLOWING DAY THAT THE INITIAL TEST WAS PERFORMED USING AN EXPIRED KIT, SO THE TEST WAS REPEATED USING A CURRENT LOT. THE REPEAT TESTING DETECTED THE FOLLOWING ORGANISMS: CAMPYLOBACTER, ENTEROAGGREGATIVE E. COLI (EAEC), ENTEROPATHOGENIC E. COLI (EPEC), SHIGELLA / ENTEROINVASIVE E. COLI (EIEC), AND NOROVIRUS GI/GII. DUE TO THE DISCREPANT RESULTS AND THE DETECTION OF ORGANISM, THE PANEL WAS REPEATED ONCE MORE. THE 3RD RUN DETECTED THE FOLLOWING: CAMPYLOBACTER, ENTEROAGGREGATIVE E. COLI (EAEC), ENTEROPATHOGENIC E. COLI (EPEC), SHIGELLA / ENTEROINVASIVE E.COLI (EIEC), AND SAPOVIRUS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9028561 ↗
• DeathJul 11, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  AN ARTICLE BY FICA ET AL1 DESCRIBES A PATIENT DEATH CASE INVOLVING A POTENTIALLY DISCREPANT ADENOVIRUS (ADV) RESULT (POTENTIALLY MORE THAN ONE RESULT) ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL. THE PATIENT DIED DUE TO RENAL FAILURE, AND THE ARTICLE CLAIMS THAT THE FILMARRAY GI PANEL RESULT(S) DELAYED APPROPRIATE TREATMENT AND ALLOWED CLINICAL DETERIORATION OF THE PATIENT. NO OTHER COMPARATOR METHODS WERE PERFORMED ON THE SAMPLE, AND THE FILMARRAY GI PANEL TEST RUN FILE(S) WAS NOT PROVIDED. TESTING OF A COLONIC BIOPSY SPECIMEN WITH ANOTHER MOLECULAR METHOD DETECTED AN ADENOVIRUS (UNKNOWN SPECIES/SUBTYPE; THE FILMARRAY GI PANEL ONLY DETECTS ADV F40 AND F41). BASED ON THE INFORMATION PROVIDED, INTERNAL INVESTIGATION CONCLUDED THAT INSUFFICIENT INFORMATION WAS AVAILABLE TO DETERMINE IF AN ERROR OCCURRED. IT IS POSSIBLE THAT THE ADV DETECTED WAS NOT ADV F40 OR F41 (A SPECIES/SUBTYPE NOT TARGETED BY THE FILMARRAY GI PANEL); IT IS ALSO POSSIBLE THAT THE LEVEL OF ADV WAS BELOW THE LIMIT OF DETECTION FOR THE FILMARRAY GI PANEL. ADDITIONALLY, THE SPECIMEN USED (RAW STOOL) IS AN OFF-LABEL SAMPLE TYPE. REFERENCES: FICA A, CATALDO P, ACEITUNO D, VILLARROEL MI, ESCALONA A. FATAL NOSOCOMIAL HE

  Patient problems: Colitis; Death

  MAUDE report 8782289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140407, K143005, K160459, K230404, K242367. One submission often covers many models, so check the product and lot details in each record.

• Z-1451-2020 · Aug 8, 2019 · Terminated
  FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
• Z-1242-2019 · Mar 6, 2019 · Terminated
  FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Pane