Device recall

Z-0778-04: NOW RSV Test Item Number 430-430, Kit Number 430-00R

FDA device recall · Class II · Binax, Inc.

Key facts

Recall number (Z-number) Z-0778-04
Recall event 28457
Product NOW RSV Test Item Number 430-430, Kit Number 430-00R
Product code GQG
Recalling firm Binax, Inc.
Recall class Class II
Status Terminated
Termination date Aug 9, 2004
510(k) numbers K032166
FEI number 1221359

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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