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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Gastrointestinal (GI) Panel

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  Class 2 Device Recall FilmArray Gastrointestinal (GI) Panel see related information
Date Initiated by Firm March 06, 2019
Create Date April 27, 2019
Recall Status1 Terminated 3 on February 18, 2022
Recall Number Z-1242-2019
Recall Event ID 82338
510(K)Number K140407  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
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.
Code Information Lots with an expiration date of 23 October 2019 onward
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Customer Support Department
800-735-6544 Ext. 360
Manufacturer Reason
for Recall		 Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PCH and Original Applicant = Biofire Diagnostics
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