Z-1139-2024 Class II Ongoing

Recalled by BioFire Diagnostics, LLC — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
February 21, 2024
Initiation Date
January 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,910 panels/pouches

Product Description

BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

Reason for Recall

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Brunei, Bolivia, Brazil, Canada, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Cech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgia, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Mongolia, Macau, Mexico, Malaysia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.

Code Information

For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Numbers: All non-expired BCID2 Panel lots, if used with the BD BACTEC vials including but not limited to, the bottle types listed in Table 1. NOTE: The affected blood culture vial types most likely contain non-viable Candida tropicalis nucleic acid/DNA fragments that can be detected by the BCID2 Panel. Therefore, all lots of the BioFire BCID2 Panel would be affected if they are used with the affected blood culture vials. Neither the BioFire BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.