Device recall

Z-3054-2011: @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use…

FDA device recall · Class II · Jay Bird Investments Inc

Key facts

Recall number (Z-number) Z-3054-2011
Recall event 59276
Product @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
Product code GTY
Recalling firm Jay Bird Investments Inc
Recall class Class II
Status Terminated
Termination date Jun 20, 2012
FEI number 3007282976

At a glance

  • None 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)