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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Blood Culture Identification (BCID) Panel

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  Class 2 Device Recall FilmArray Blood Culture Identification (BCID) Panel see related information
Date Initiated by Firm July 20, 2021
Create Date August 12, 2021
Recall Status1 Terminated 3 on December 16, 2022
Recall Number Z-2245-2021
Recall Event ID 88410
510(K)Number K181493  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product FilmArray Blood Culture Identification (BCID) Panel

Product Pouch Label:
FilmArray BCID Panel

Part No: RFIT-ASY-0126
Part No: RFIT-ASY-0127
Code Information Part No: RFIT-ASY-0126 / UDI: 00815381020086;  Part No: RFIT-ASY-0127 / UDI: 00815381020093;  Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003 
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
800-736-6544 Ext. 5
Manufacturer Reason
for Recall		 Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
FDA Determined
Cause 2		 Process control
Action On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at Support@biofiredx.com or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.
Quantity in Commerce 29 kits
Distribution U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PEN and Original Applicant = BioFire Diagnostics, LLC
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