BioFire Diagnostics, LLC: Medical Device Recall in 2018 - (Recall #: Z-1513-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 14, 2018

Date Posted: May 2, 2018

Recall Number: Z-1513-2018

Event ID: 79514

Reason for Recall:

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

Status: Terminated

Product Quantity: N/A

Code Information:

All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated