BioFire Diagnostics, LLC: Device Recall

Recall #Z-1518-2025 · 02/27/2025

Class II: Risk

Recall Details

Recall Number: Z-1518-2025
Classification: Class II
Product Type: Device
Recalling Firm: BioFire Diagnostics, LLC
Status: Ongoing
Date Initiated: 02/27/2025
Location: Salt Lake City, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29 kits

Reason for Recall

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Product Description

FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

Distribution Pattern

OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

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 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 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 →

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.