BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Classification
- Class II
- Units
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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