BioFire Diagnostics, LLC: Medical Device Recall in 2019 - (Recall #: Z-1242-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 6, 2019

Date Posted: May 8, 2019

Recall Number: Z-1242-2019

Event ID: 82338

Reason for Recall:

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

Status: Terminated

Product Quantity: 17188

Code Information:

Lots with an expiration date of 23 October 2019 onward

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated