FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA Recall Z-1448-2020 · Posted 2020-02-18
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Recalling FirmBiofire Defense
Recall StatusTerminated
Product CodePRD
Date Initiated2019-08-20
Date Terminated2020-10-30
Product Quantity92 kits
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.
Firm Action
On 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 [email protected] or via telephone at 1-801-262-3592 for product technical support.
Root Cause
Labeling Change Control
Distribution Pattern
US: UT, MD, GA, CO, OH, TX, OUS: None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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