FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA device recall Z-1448-2020 · posted 2020-02-18 · Terminated
Recall details
- Recalling firm
- Biofire Defense
- 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.
- Action taken
- 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 Support@biofiredefense.com or via telephone at 1-801-262-3592 for product technical support.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- PRD
- Quantity affected
- 92 kits
- Distribution
- US: UT, MD, GA, CO, OH, TX, OUS: None
- Date initiated
- 2019-08-20
- Date posted
- 2020-02-18
- Date terminated
- 2020-10-30
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |