FDA
Food and Drug Administration · Recall Z-2936-2026 · Jun 24, 2026BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
BioFire Diagnostics, LLC
The hazard
Due to increase in false negative results FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
UPC 00815381020529Would you have heard about this one?
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