Device recall

Z-0801-2013: The product is a lyophilized growth supplement for use with dehydrated culture…

FDA device recall · Class II · Remel Inc

Key facts

Recall number (Z-number) Z-0801-2013
Recall event 63584
Product The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Product code JSK
Recalling firm Remel Inc
Recall class Class II
Status Terminated
Termination date Jun 4, 2013
FEI number 1924669

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)