Device recall

Z-1146-04: IMMAGE IGALC Reagent Part Number: 447460

FDA device recall · Class III · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1146-04
Recall event 28963
Product IMMAGE IGALC Reagent Part Number: 447460
Product code CFN
Recalling firm Beckman Coulter Inc
Recall class Class III
Status Terminated
Termination date Aug 30, 2004
510(k) numbers K993547
FEI number 2050012

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

Browse all FDA device recalls (products)