BioFire Diagnostics, LLC recalls
4 recalls filed under BioFire Diagnostics, LLC. The most recent was published August 19, 2026.
-
Class II · 2 months ago
Biofire Respiratory Panel 2.1 REF 423742 UDI code: 00815381020529 recall: Due to increase in false negative results
Due to increase in false negative results
-
Class II · 6 months ago
Biofire Spotfire recall: Respiratory/sore throat panel test may result in false negative results
Respiratory/sore throat panel test may result in false negative results and control failures.
-
Class II · 6 months ago
BioFire Joint Infection Panel REF: RFIT-ASY-0138, 30 test Kit recall: Contamination to in-vitro diagnostic test may result in false positives
Contamination to in-vitro diagnostic test may result in false positives.
-
Class II · 11 months ago
BioFire Respiratory Panel 2.1, IVD, REF: 423742 recall: Due to unintended movement of pouch chemistry
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
About this page
BioFire Diagnostics, LLC appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.