BioFire Spotfire Respiratory/Sore Throat Panel Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
BioFire Diagnostics, LLC is recalling 2400 pouches of its Spotfire Respiratory/Sore Throat Panel due to potential false negative results and control failures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 27, 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-devices.
What Happened
BioFire Diagnostics, LLC has initiated a voluntary recall because the Biofire Spotfire Respiratory/Sore Throat Panel test may result in false negative results and control failures.
Which Products Are Affected
The recall affects the Biofire Spotfire Respiratory/Sore Throat Panel, REF: 423485, Lot Number: 2215125 (UDI: 00815381020390). A total of 2400 pouches are involved. The products were distributed nationwide in the United States, specifically in the states of MS, TX, MN, and VA.
What You Should Do
Consumers and healthcare providers should follow the firm's instructions provided via the initial E-Mail notification. Contact BioFire Diagnostics, LLC for return or replacement information.
Why This Matters
The recall addresses potential inaccurate test results that could affect respiratory and sore throat diagnoses across distributed units.
Source
FDA Recall Z-2081-2026 - 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 (983 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.