FDA-Device2018-11-07Class II
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, 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,
BioFire Diagnostics, LLC
Hazard
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Sold states
Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam
Affected count
18038
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, 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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief