Z-1139-2024 Class II Ongoing
FDA device recall Z-1139-2024 was initiated by BioFire Diagnostics, LLC on January 26, 2024 and is designated Class II. Reason for recall: Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums The recall status is ongoing. Affected quantity: 32,910 panels/pouches.
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
Reason for Recall
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.