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Recall Observatory FDA recall evidence

Device product

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

Z-0602-2026

October 22, 2025

Class II

Product summary

Firm
BioFire Diagnostics, LLC
Event
Event 97870
Status
Ongoing
Classification
Class II
Quantity
97 Kits (2,910 pouches)
Official record key
device-enforcement:Z-0602-2026

Official wording

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

Code information: UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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