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 4
Check against the official notice below — it lists the full affected range.
BioFire Diagnostics is recalling 14,140 kits of BioFire Blood Culture Identification 2 (BCID2) Panel and associated BD BACTEC blood culture media products distributed worldwide and nationwide in the U.S. The recall affects kits with expiration dates of April 30, 2022 or earlier due to an increased risk of false positive results for Acinetobacter calcoaceticus-baumannii complex, which may be caused by non-viable contamination in the blood culture vials.
The recall includes 11,155 kits distributed in the U.S. across all states, as well as 2,985 kits distributed internationally. The affected products include multiple catalog numbers and configurations of blood culture media in both plastic and glass vials. The source document does not specify a remedy or recommended actions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Cz Quantity: Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)] 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.