Device recall

Z-1150-04: IMMAGE IgM Reagent Part No.: 447610

FDA device recall · Class III · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1150-04
Recall event 29094
Product IMMAGE IgM Reagent Part No.: 447610
Product code DEW
Recalling firm Beckman Coulter Inc
Recall class Class III
Status Terminated
Termination date Aug 30, 2004
510(k) numbers K963868
FEI number 2050012

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

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