Device recall

Z-2067-2026: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

FDA device recall · Class II · BioFire Diagnostics, LLC

Key facts

Recall number (Z-number) Z-2067-2026
Recall event 98776
Product BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Product code QSN
Recalling firm BioFire Diagnostics, LLC
Recall class Class II
Status Open, Classified
FEI number 3002773840

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)