Recall Z-1448-2020 ยท PRD
Biofire Defense
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
| Date | Feb 18, 2020 (initiated Aug 20, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| 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 F |
| Quantity | 92 kits |
| Distribution | US: UT, MD, GA, CO, OH, TX, OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170883 | FilmArray NGDS Warrior Panel Biofire Defense, LLC, Jun 22, 2017 |