Device recall

Z-0371-05: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).

FDA device recall · Class II · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-0371-05
Recall event 30395
Product UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
Product code JJE
Recalling firm Beckman Coulter Inc
Recall class Class II
Status Terminated
Termination date Mar 16, 2005
510(k) numbers K023764
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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