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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

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  Class 2 Device Recall FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch see related information
Date Initiated by Firm August 08, 2019
Create Date March 06, 2020
Recall Status1 Terminated 3 on April 12, 2022
Recall Number Z-1451-2020
Recall Event ID 84825
510(K)Number K140407  K143005  K160459  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Code Information Kit Lot: 0537319 / Pouch Lot: 681619  Pouch Lot Date of Expiration 2020-05-30
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Customer Support Department
1800-735-6544 Ext. 5
Manufacturer Reason
for Recall		 Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
FDA Determined
Cause 2		 Employee error
Action on August 8, 2019, a "Urgent: Medical Device Recall (Removal)" letter was sent to all affected consignees via FedEx priority-overnight. The notification informed consignees about the recall and asked they take the following actions: Requested Actions: " Please immediately examine your inventory for BioFire GI Panel reagents with kit lot number 0537319. The lot number can be found on the product label outside of the reagent box. " If reagents with the related kit lot number are found, please stop using the affected product, quarantine them, and call BioFire Technical Support to have the product returned. The BioFire Technical Support Team can assist with shipping logistics and provide a replacement. " Complete and return the enclosed Acknowledgement of Receipt Form as soon as possible and return to BioFire via one of the methods listed on the form. " If you have any questions or concerns, please dont hesitate to contact our 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 23 kits (690 pouches)
Distribution US: KY, IL, NJ, MS
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 = PCH and Original Applicant = Biofire Diagnostics
510(K)s with Product Code = PCH and Original Applicant = BioFire Diagnostics, LLC
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