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U.S. Department of Health and Human Services

Class 3 Device Recall FilmArray NGDSWarrior Panel kit

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 Class 3 Device Recall FilmArray NGDSWarrior Panel kitsee related information
Date Initiated by FirmAugust 20, 2019
Date PostedFebruary 18, 2020
Recall Status1 Terminated 3 on October 30, 2020
Recall NumberZ-1448-2020
Recall Event ID 84887
510(K)NumberK170883 
Product Classification Biothreat microbial agents multiplex nucleic acid detection system - Product Code PRD
ProductFilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Code Information Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10
FEI Number 3010770794
Recalling Firm/
Manufacturer		 Biofire Defense
79 W 4500 S
Ste 14
Salt Lake City UT 84107-2649
For Additional Information ContactBFDf Customer Support
801-262-3592
Manufacturer Reason
for Recall		The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 8/20/2019, a "Urgent: Customer Recall Notice" letter was sent to all affected consignees informing them on the recall. In addition to providing information on the recall, the firm asked consignees do the following: 1. BFDf has enclosed a replacement printed copy of the Revision 02 Warrior IFU with this notice. BFDf advises customers to remove and dispose of all incorrect IFUs included in non-expired product from the affected lots listed. BFDf will provide additional replacement copies of the IFU on request. 2. Please complete and return the accompanying Recall Acknowledgement of Receipt Form included with this Notice, using one of the listed methods to confirm your receipt of this notification. 3. If you have any additional questions or concerns, please do not hesitate to contact BFDf Customer Support via email at Support@biofiredefense.com or via telephone at 1-801-262-3592 for product technical support.
Quantity in Commerce92 kits
DistributionUS: UT, MD, GA, CO, OH, TX, OUS: None
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) Database510(K)s with Product Code = PRD
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