Device recall

Z-0459-2008: Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-0459-2008
Recall event 38897
Product Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler…
Product code JJF
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Sep 8, 2008
510(k) numbers K033734
FEI number 1823260

At a glance

  • 1–9 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

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