Recall Z-1133-2019— BioFire Diagnostics, LLC
Class II · Terminated
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2019-03-07, terminated 2022-08-24. It names 4 FDA 510(k) clearances: K181493, K160457, K143171 and 1 more. Product: FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853. Reason: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-07
- Terminated
- 2022-08-24
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
4 on FDA's record- K181493 — FilmArray Blood Culture Identification (BCID) Panel
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
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 BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
Reason for recall
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Data sourced from openFDA. This site is unofficial and independent of the FDA.