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Open, Classified

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

FDA Recall Z-1877-2025 · Posted 2025-05-29

Recalling FirmBioFire Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeOCC
Date Initiated2025-04-30
Product Quantity30 kits

Reason for Recall

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Firm Action

On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for the lot identified in this field safety notice. 2. Discontinue use and discard any remaining product from this lot in your possession. 3. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed on the attached Acknowledgement of Receipt Form. 4. If you have further distributed this product, please identify any recipients and notify them at once. 5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution in the country of Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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