Device recall

Z-0475-06: COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381…

FDA device recall · Class III · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-0475-06
Recall event 34380
Product COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
Product code GKJ
Recalling firm Beckman Coulter Inc
Recall class Class III
Status Terminated
Termination date Jan 26, 2012
510(k) numbers K962988
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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