Device recall

Z-0181-2014: Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.

Key facts

Recall number (Z-number) Z-0181-2014
Recall event 66267
Product Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Product code DLZ
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Terminated
Termination date Aug 27, 2014
510(k) numbers K011528, K913190
FEI number 2517506

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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