Device recall

Z-0565-2007: CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000…

FDA device recall · Class III · Abbott Laboratories

Key facts

Recall number (Z-number) Z-0565-2007
Recall event 37234
Product CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
Product code GIF
Recalling firm Abbott Laboratories
Recall class Class III
Status Terminated
Termination date Nov 28, 2007
510(k) numbers K051215, K061667, 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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