Z-1242-2019Class II

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and...

Name: Z-1242-2019 FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and...
Creator: BioFire Diagnostics, LLC
Published: 2019-03-06
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2019-03-06 / Terminated / root cause: design

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray... on 2019-03-06. FDA classified it as Class II and gives the reason as "Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1242-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-06
Posted: 2019-04-27
Terminated: 2022-02-18
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
Root cause tag: design
FDA root cause: Device Design
Action: On 03/05/19, Urgent Medical Device Recall (Correction) notices were mailed to customers. Customers were advised, that if they used affected devices, positive Campylobacter and Cryptosporidium results should be confirmed by another method prior to reporting the test results. The firm advised customers that the issue was currently under investigation and they would notify customers if additional pertinent information was uncovered. Customers that further distributed product were asked to notify their customers at once of this product recall. As of 02/26/19, the firm temporarily stopped shipment of affected devices. Customers were asked to complete and return the Acknowledgment of Receipt Form. The following contact information was on the safety notice: 1-800-735-6544 and 801-736-6354. On 03/13/19, Urgent Medical Device Recall (Correction) notices were mailed to customers. Customers were advised that this was an expansion/revision of the previous notice) to include newly manufactured GI panel kit lots and to provide revised recommended actions for use of the affected product. Firm resumed shipment of the product with the following limitations: Limitations: - Users may experience combined rates of false positive Campylobacter and Cryptosporidium results ranging from 0 - 9% while using the GI Panel. The majority of product is expected to exhibit rates below 3%. - For specimens that test positive for Campylobacter and/or Cryptosporidium on the GI Panel: Results should be confirmed by retesting using a new GI Panel pouch or by an alternative assay for Campylobacter and/or Cryptosporidium. Only results from confirmatory retesting for Campylobacter and/or Cryptosporidium should be reported for that analyte. - If confirmatory testing is performed with the GI Panel overall specificity is estimated to be (>99%) of both of these analytes, but may also result in a small reduction in sensitivity (by approximately 2-2.5%; from 97.1% to 94.7% for Campylobacter and
Quantity in commerce: 17188
Distribution: Worldwide Distribution - US Nationwide in the states of: CO, IL, NJ, PA, OH, FL, KY, NE, NY, CA, WV, UT, TX, MS, OK, WI, NC, DE, IN, MN, AK, ND, GA, AR, MO, KS, HI, IA, LA, VA, SC, MT, NM, SD, AL, WY, AZ, WA, TN, OR, MI, MA, NV, MD, CT, DC, VT, ID, NH, RI, ME. Foreign (OUS): Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Ivory Coast, Chile, Colombia, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, South Africa, Utd.Arab Emir., Puerto Rico,Dutch Antilles,Angola, Bangladesh, Burkina Faso, Bulgaria, Bahrain, Bermuda, Botswana, Dem. Rep. Congo, Costa Rica, Dominican Rep., Algeria, Ecuador, Estonia, Egypt, Gabon, Georgia, Guatemala, Guam, Croatia, Haiti, Israel, Iraq, Jordan, Kenya, Kuwait, Lebanon, Morocco, Macedonia, Malta, Malaysia, Nicaragua, Oman, Panama, Peru, Philippines, Pakistan, Qatar, Romania, Serbia, Saudi Arabia, Slovenia, El Salvador, Uruguay, Vietnam, Denmark, Slovakia
Product codes and lots: Lots with an expiration date of 23 October 2019 onward

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1242-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1242-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code PCH

K140407Class IIFilmarray Gastrointestinal (Gi) PanelBiofire Diagnostics / cleared 2014-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)