Recall Z-3122-2024 ยท NSU Instrumentation For Clinical Multiplex Test Systems
BioFire Diagnostics, LLC
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
| Date | Sep 11, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| Reason | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA. |
| Root cause | Under Investigation by firm |
| Action | On 8/7/24 Biomerieux sent recall notices to customers who were asked to do the following: 1) Utilize http://biofiredx.com/fsca5788-1/ to determine which of your instruments are impacted. 2) If your instrument is on the impacted list, it needs to be returned to the firm's Service Center for recalibration; your local contact will reach out to you to coordinate instrument return. 3) Continue to use all your instruments in accordance with product labeling (instructions for use) while waiting for service. 4) For BIOFIRE GI Panel Users, you may continue using the product as directed in the packa |
| Quantity | 1001 |
| Distribution | Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143178 | FilmArray 2.0 System Biofire Diagnostics, LLC, Jan 30, 2015 |