Recall Z-3123-2024— BioFire Diagnostics, LLC

Name: FDA recall Z-3123-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-07

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2024-08-07. It names one FDA 510(k) clearance: K160068. Product: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U. 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..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-08-07
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K160068 — FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC·cleared 2016-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.