Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA Recall Z-2081-2026 · Posted 2026-05-06
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Recalling FirmBioFire Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeQOF
Date Initiated2026-04-01
Product Quantity2400 pouches
Reason for Recall
Respiratory/sore throat panel test may result in false negative results and control failures.
Firm Action
On April 1, 2026, Biomerieux, issued a "Urgent Medical Device Recall" via E-Mail. Biomerieux ask consignees to take the following actions:
In this context, we request that you take the following actions:
" Examine your inventory for the lot identified in this recall notice.
"Discontinue use and discard any remaining product from this lot in your possession.
"Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form.
"If you have further distributed this product, please identify any recipients and notify them at once.
" Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of MS, TX MN, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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