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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Culture Identification 2 (BCID2) Panel

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  Class 2 Device Recall Blood Culture Identification 2 (BCID2) Panel see related information
Date Initiated by Firm October 11, 2021
Create Date November 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-0312-2022
Recall Event ID 88934
510(K)Number K193519  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product 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
Code Information 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.
Recalling Firm/
Manufacturer
BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
800-735-6544 Ext. 5
Manufacturer 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.
FDA Determined
Cause 2
Material/Component Contamination
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 Support@biofiredx.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support.
Quantity in Commerce Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]
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/.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PEN and Original Applicant = BioFire Diagnostics, LLC
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