BioFire Diagnostics, LLC recalls FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127

Recalled May 2, 2018 · FDA recall Z-1513-2018 · BioFire Diagnostics

Hazard

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

Units

N/A

Sold at

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, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.

Description

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

Product

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.

Manufacturer(s)

BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →