Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to(
FDA device recall Z-0571-2014 · posted 2013-12-24 · Terminated
Recall details
- Recalling firm
- Data Innovations, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 24 systems
- Distribution
- Nationwide Canada and Britain
- Date initiated
- 2013-11-06
- Date posted
- 2013-12-24
- Date terminated
- 2014-12-05
- Location
- South Burlington, VT
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