Device recall

Z-1440-06: UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers…

FDA device recall · Class II · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1440-06
Recall event 35646
Product UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Product code NDW
Recalling firm Beckman Coulter Inc
Recall class Class II
Status Terminated
Termination date Apr 8, 2013
510(k) numbers K042291DX, K060256DX
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

Browse all FDA device recalls (products)