FDA recall Z-0296-2019

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 for recall

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

Distribution

Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam

Key facts

Status

Terminated

Initiation date

2018-09-05

Report date

2018-11-07

Termination date

2021-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2019