Device recall

Z-0708-2007: CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01…

FDA device recall · Class II · Abbott Laboratories

Key facts

Recall number (Z-number) Z-0708-2007
Recall event 37454
Product CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Product code GIF
Recalling firm Abbott Laboratories
Recall class Class II
Status Terminated
Termination date Nov 28, 2007
510(k) numbers K051215, K961439
FEI number 2919069

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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