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Terminated

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

FDA Recall Z-0312-2022 · Posted None

Recalling FirmBioFire Diagnostics, LLC
Recall StatusTerminated
Product CodePEN
Date Initiated2021-10-11
Date Terminated2023-08-10
Product QuantityTotal 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]

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.

Firm Action

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 [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support.

Root Cause

Material/Component Contamination

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/.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC · 2020-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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