BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- October 11, 2021
- Terminated
- August 10, 2023
- Recall Number
- Z-0312-2022
- Quantity
- Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]
- Firm Location
- Salt Lake City, UT
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.
Distribution
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/.
Lot / Code Info
Blood Culture Identification 2 (BCID2) Panel Part Number: RFIT-ASY-0147 UDI Code: 00815381020338 Blood Culture Media Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All BCID2 Panel lots BD Blood Culture Media vials with expiration date of April 30, 2022 or earlier.
Root Cause
Material/Component Contamination
Action Taken
On or about 10/10/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to U.S. customer via overnight FedEx to inform them that there is an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results when the blood culture identification panels are used with some types of blood culture vials. The increased risk are potential due to an increased level of nucleic acid from non-viable Acinetobacter calcoaceticus- baumannii complex targets in the blood culture vials. Affected Blood Culture Media vials are: 442023 - BD BACTEC Plus Aerobic medium in plastic vials; 442021 - BD BACTEC Lytic Anaerobic medium in plastic vials; 442192 - BD BACTEC Plus Aerobic medium in glass vials; 442022 - BD BACTEC Plus Anaerobic medium in plastic vials; 442020 - BD BACTEC Peds Plus mediums in plastic vials; Customers are instructed to: 1) If the BCID2 Panel is used to test BD BACTEC" blood culture vials with an expiration date of April 30, 2022 or earlier, positive results for Acinetobacter calcoaceticus- baumannii complex should be confirmed by another method prior to reporting the test results. 2) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to the Recalling Firm via one of the listed return methods so that the Recalling Firm may acknowledge their receipt of this notification. Any questions or concerns, contact customer support department at Support@biofiredx.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support.