Device recall

Z-1021-04: COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan…

FDA device recall · Class I · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-1021-04
Recall event 29061
Product COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
Recalling firm Roche Diagnostics Corp.
Recall class Class I
Status Terminated
Termination date Jul 24, 2007
FEI number 1823260

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event

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)