The Recall Desk
ModerateFDA (Devices)·Z-0571-2014·Announced 2014-01-01

Data Innovations Instrument Manager Driver Software Recall for Sysmex UF-100

Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential sample errors without reported injuries or illnesses, fitting the criteria for a moderate severity rating.

Plain-English summary

Data Innovations, Inc. is recalling the Instrument Manager driver software (sysu100i) used to connect to the Sysmex UF-100 analyzer. The recall affects specific software versions prior to v7.00.0006 and v8.00.0005, including versions 7.00.0001 through 7.00.0005 and 8.00.0001 through 8.00.0004.

The recall was initiated because the software, when configured with the "Strip Zeros from Result" option set to "Yes," may result in sample errors. This issue could affect the accuracy of data processing for the connected analyzer.

Approximately 24 systems were distributed nationwide, as well as in Canada and Britain. Users of the affected software versions should contact Data Innovations, Inc. for further instructions on how to resolve the issue.

The recalled product

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
Manufacturer
Data Innovations, Inc.
Category
Medical Device — Software
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Software alll versions prior to: v7.00.0006 and v8.00. Includes: 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · software error

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