Device recall

Z-2006-2021: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number…

FDA device recall · Class II · Luminex Corporation

Key facts

Recall number (Z-number) Z-2006-2021
Recall event 88137
Product Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Product code OCC
Recalling firm Luminex Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K143653
FEI number 3006028115

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)