Device recall

Z-1014-2012: West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA…

FDA device recall · Class II · Inverness Medical

Key facts

Recall number (Z-number) Z-1014-2012
Recall event 50701
Product West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with…
Product code NOP
Recalling firm Inverness Medical
Recall class Class II
Status Terminated
Termination date Feb 15, 2012
510(k) numbers K041231
FEI number 3006781044

At a glance

  • 1–9 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

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