Device recall

Z-0609-05: Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-0609-05
Recall event 30664
Product Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Jun 30, 2005
510(k) numbers K932642, K972673
FEI number 1823260

At a glance

  • 1–9 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)