Device recall

Z-1015-05: Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

FDA device recall · Class II · Diagnostic Products Corp

Key facts

Recall number (Z-number) Z-1015-05
Recall event 32268
Product Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Product code DHX
Recalling firm Diagnostic Products Corp
Recall class Class II
Status Terminated
Termination date Feb 3, 2006
510(k) numbers K970877
FEI number 3005250747

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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