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Terminated

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

FDA Recall Z-0571-2014 · Posted 2013-12-24

Recalling FirmData Innovations, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2013-11-06
Date Terminated2014-12-05
Product Quantity24 systems

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

Firm Action

Data Innovation notified consignees by Important Medical Device Recall Notification dated 11/5/13 to all list serv recipients of the problem and posted critical alert on Customer Web Portal. A certified letter was issued to impacted customers and consignees if no response was recieved from e-mail.

Root Cause

Software design

Distribution Pattern

Nationwide Canada and Britain

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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