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Class 2 Device Recall FilmArray Blood Culture Identification (BCID) Panel/ Blood Culture Identification 2 (BCID2) Panel |
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Date Initiated by Firm |
January 26, 2021 |
Create Date |
March 01, 2021 |
Recall Status1 |
Terminated 3 on May 02, 2022 |
Recall Number |
Z-1158-2021 |
Recall Event ID |
87282 |
510(K)Number |
K193519
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Product Classification |
Gram-Negative bacteria and associated resistance markers - Product Code PEN
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Product |
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
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Code Information |
All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020. |
Recalling Firm/ Manufacturer |
BioFire Diagnostics, LLC 515 S Colorow Dr Salt Lake City UT 84108-1248
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For Additional Information Contact |
Customer Support Department 800-735-6544
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Manufacturer Reason for Recall |
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
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FDA Determined Cause 2 |
Other |
Action |
On or around January 25, 2021, the firm send an UGENT: MEDICAL DEVICE CORRECTION letter via email to all affected consignees. The firm's recall strategy includes notification of all customers who have ordered the BCID or BCID2 Panel, within the last 12 months, using the aforementioned Customer Letters. The effectiveness of this communication will be verified by monitoring confirmation of the Acknowledgment of Receipt from each affected customer. |
Quantity in Commerce |
5,220 kits |
Distribution |
Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam. |
Total Product Life Cycle |
TPLC Device Report
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = PEN and Original Applicant = BioFire Diagnostics, LLC
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