Z-0571-2014Class II

Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions...

Name: Z-0571-2014 Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions...
Creator: Data Innovations, Inc.
Published: 2013-11-06
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2013-11-06 / Terminated / root cause: software

FDA source

Data Innovations, Inc. began a recall of 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... on 2013-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0571-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Posted: 2013-12-24
Terminated: 2014-12-05
Recalling firm: Data Innovations, LLC
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 24 systems
Distribution: Nationwide Canada and Britain
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)