Device recall

Z-1529-2008: Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager…

FDA device recall · Class II · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1529-2008
Recall event 46370
Product Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Product code GKZ
Recalling firm Beckman Coulter Inc
Recall class Class II
Status Terminated
Termination date Oct 15, 2012
510(k) numbers K030828
FEI number 2050012

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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