Biofire Defense Recalls FilmArray NGDS Warrior Panel Due to Incorrect Instructions
Biofire Defense is recalling 92 kits of the FilmArray NGDS Warrior Panel because the kits included an incorrect instruction for use (IFU) revision.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation error (incorrect IFU) rather than a direct physical hazard.
Plain-English summary
Biofire Defense is recalling 92 kits of the FilmArray NGDS Warrior Panel, a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit. The recall was initiated because the firm identified that an incorrect instruction for use (IFU) revision was included in the kits.
The affected product is identified by Reference NGDS-ASY-0007 and UDI (01)00851458005136. The recall covers specific lots with expiration dates ranging from October 2018 to June 2020. The product was distributed in the United States to Utah, Maryland, Georgia, Colorado, Ohio, and Texas.
Healthcare providers and facilities should stop using the affected kits and contact Biofire Defense for further instructions. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
- Manufacturer
- Biofire Defense
- Hazard
- Affected units
- 92
Distribution
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