BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

FDA device recall Z-0602-2026 · posted 2025-11-26 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Action taken

On May 28, 2026, Biomerieux issued a "Urgent: Medical Device Recall" Expansion Notification to affected consignees via E-Mail. Initial notification was sent out on October 22, 2025. Biomerieux asked consignees to take the following actions: 1. 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. Please confirm the quantity of kits that have been destroyed, previously used, or returned 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. 6. Complete and submit the report online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QOF

Quantity affected

97 Kits (2,910 pouches)

Distribution

US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None

Date initiated

2025-10-22

Date posted

2025-11-26

Location

Salt Lake City, UT