BioFire Diagnostics, LLC recalls FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-012…

Recall date

March 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1513-2018

FDA classification

Class II

Brand / firm

BioFire Diagnostics, LLC

Sold / distributed

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Ge…

Why it was recalled

There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.