DeviceClearance

Recall Z-0296-2019— BioFire Diagnostics, LLC

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2018-09-05, terminated 2021-03-22. It names 4 FDA 510(k) clearances: K181493, K160457, K143171 and 1 more. Product: 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,. Reason: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles..

Recalling firm
BioFire Diagnostics, LLC
Classification
Class II
Status
Terminated
Initiated
2018-09-05
Terminated
2021-03-22
Firm location
Salt Lake City, UT, United States

510(k) clearances named in this recall

4 on FDA's record

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 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,

Reason for recall

Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.

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