Device recall

Z-1663-2016: Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

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

Key facts

Recall number (Z-number) Z-1663-2016
Recall event 73667
Product Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Product code JHM
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Terminated
Termination date Sep 25, 2017
510(k) numbers K073072
FEI number 2517506

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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