Device recall

Z-0571-2014: Instrument Manager driver: Driver sysu100i that connects to the Sysmex UF-100…

FDA device recall · Class II · Data Innovations, Inc.

Key facts

Recall number (Z-number) Z-0571-2014
Recall event 66754
Product Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
Product code JQP
Recalling firm Data Innovations, Inc.
Recall class Class II
Status Terminated
Termination date Dec 5, 2014
FEI number 3001451449

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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