Z-0083-2012

Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package...

Name: Z-0083-2012 Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package...
Creator: Data Innovations, Inc.
Published: 2009-05-11
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2009-05-11 / Terminated / root cause: software

FDA source

Data Innovations, Inc. began a recall of Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory... on 2009-05-11. The reason FDA records is "The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result"". 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-0083-2012
Status: Terminated
Initiated: 2009-05-11
Posted: 2011-10-21
Terminated: 2011-10-25
Recalling firm: Data Innovations, LLC
Product: Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result".
Root cause tag: software
FDA root cause: Software design
Action: Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.
Quantity in commerce: 188
Distribution: USA (nationwide) and the country of Canada.
Product codes and lots: S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.

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)