Z-0312-2022 Class II Terminated
FDA device recall Z-0312-2022 was initiated by BioFire Diagnostics, LLC on October 11, 2021 and is designated Class II. Reason for recall: Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials. The recall status is terminated (terminated August 10, 2023). Affected quantity: Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)].
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 11, 2021
- Termination Date
- August 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The Countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Dominican Rep/, Ecuador, Egypt, France, Georgia, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Israel Italy, Kuwait, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Shanghai, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/.