Recall Z-1242-2019 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioFire Diagnostics, LLC
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.
| Date | Mar 6, 2019 |
| Status | Terminated |
| Reason | Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. |
| 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 shipm |
| Quantity | 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, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL Biofire Diagnostics, May 2, 2014 |