Device recall

Z-0807-05: Programming software (all versions) for Polymedco PolyTiter Immunofluorescent…

FDA device recall · Class III · Diasorin Inc.

Key facts

Recall number (Z-number) Z-0807-05
Recall event 30946
Product Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
Product code DHN
Recalling firm Diasorin Inc.
Recall class Class III
Status Terminated
Termination date Jul 22, 2006
510(k) numbers K822397
FEI number 2182595

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)