Company: Data Innovations, Inc.
Date of Enforcement Report:1/1/2014
Class lI:
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
Recall Number Z-0571-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., Burlington, VT on 11/6/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24 systems
DISTRIBUTION
Nationwide andI Internationally
___________________________________
