BioFire Respiratory Panel 2.1 Recall
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BioFire Diagnostics, LLC is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 due to an increase in false negative results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
BioFire Diagnostics, LLC initiated a voluntary recall of the BIOFIRE Respiratory Panel 2.1 due to an increase in false negative results.
Which Products Are Affected
The recall affects the BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 with UDI code 00815381020529. A total of 2,370 pouches (79 kits) are involved. Affected lots include Pouch Lot 3VLB25 and Kit Lot 1872125. The products were distributed to U.S. Nationwide locations in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. The recall number is Z-2936-2026.
What You Should Do
The recall is ongoing and classified as Class II. Consumers and healthcare providers should refer to the recalling firm or FDA for guidance on affected units.
Why This Matters
The recall addresses potential inaccuracies in an in vitro diagnostic test used for respiratory pathogen detection.
Source
FDA recall Z-2936-2026, BioFire Diagnostics, LLC, Salt Lake City, UT.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (960 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.