Home / Recalls / Data Innovations, Inc. / Z-0571-2014

Z-0571-2014 Class II Terminated

Recalled by Data Innovations, Inc. — South Burlington, VT

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 6, 2013
Termination Date
December 5, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 systems

Product Description

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

Reason for Recall

When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may result in sample error

Distribution Pattern

Nationwide Canada and Britain

Code Information

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

Other recalls by Data Innovations, Inc.

  • Z-0203-2019 Class II — IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software prod (August 29, 2018)
  • Z-1680-2017 Class II — JResultNet drivers using ASTM coding language. Calculator/data processing modul (October 23, 2014)
  • Z-2637-2014 Class II — ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResu (August 15, 2014)