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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire FilmArray Meningitis/Encephalitis (ME) Panel

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 Class 2 Device Recall BioFire FilmArray Meningitis/Encephalitis (ME) Panelsee related information
Date Initiated by FirmSeptember 10, 2018
Create DateNovember 10, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0446-2019
Recall Event ID 81197
Product Classification Meningitis/Encephalitis pathogen multiplex nucleic acid detection system - Product Code PLO
Product-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Code Information ME Panel Kit Lot No. ME Pouch Lot. No. Kit Expiration Date 580818 892018 4/2/2019 584418 896018 4/5/2019  Note - Kits contain a Primer Pill Lot 210318. The Primer Pill is a freeze dried/lyophilized "pellet" that contains all of the primers and buffer used in the PCR1 reaction.
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
801-736-6354 Ext. 360
Manufacturer Reason
for Recall		Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 09/10/2018, the firm sent an Urgent Medical Device Recall Letter via FedEx to the Recall Coordinator/Laboratory Director for all consignees. Consignees are instructed to: -Immediately examine their inventory for products with the affected Lot numbers and to discontinue use and to discard any remaining product in their possession that is subject to the recall.. BioFire will replace discarded product at no charge. -If the consignee has further distributed the affected product, they are to identify these customers and to notify them at once of the product recall. -Complete and return the Acknowledgement of Receipt Form that was enclosed with the Customer Advisory Notice letter, as soon as possible, and to return the Acknowledgement Form to the firm. Consignees were provided with firm contact information including phone numbers: 801-736-6354 and 1-800-735-6544
Quantity in Commerce1350 pouches
DistributionWorldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico
Total Product Life CycleTPLC 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.
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