BioFire Diagnostics, LLC: Device Recall

Recall Details

Recall Number

Z-3122-2024

Classification

Class II

Product Type

Device

Recalling Firm

BioFire Diagnostics, LLC

Status

Ongoing

Date Initiated

08/07/2024

Location

Salt Lake City, UT, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1001

Reason for Recall

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.

Product Description

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Distribution Pattern

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, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.

Other Recalls by BioFire Diagnostics, LLC

• Class II: Risk 10/22/2025
  Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
• Class II: Risk 04/30/2025
  Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
• Class II: Risk 02/27/2025
  Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
• Class II: Risk 08/07/2024
  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.
• Class II: Risk 06/19/2024
  If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

View all recalls by BioFire Diagnostics, LLC →