BioFire Diagnostics, LLC

9 FDA enforcement actions

9 Total Recalls

0 Class I

9 Class II

0 Class III

Firm Details

Product Types: device
States: UT

All Recalls

Class II: Risk 10/22/2025 device

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 device

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Class II: Risk 02/27/2025 device

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Class II: Risk 08/07/2024 device

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 08/07/2024 device

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 device

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.
Class II: Risk 06/10/2024 device

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Class II: Risk 06/10/2024 device

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Class II: Risk 05/16/2024 device

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.