Device recall

Z-0574-06: Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material #…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-0574-06
Recall event 34590
Product Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
Product code LFW
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Jun 23, 2006
510(k) numbers K912143
FEI number 1823260

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

Browse all FDA device recalls (products)