Z-0167-2007

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using...

Name: Z-0167-2007 Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using...
Creator: Data Innovations, Inc.
Published: 2006-08-10
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2006-08-10 / Terminated

FDA source

Data Innovations, Inc. began a recall of Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R) on 2006-08-10. The reason FDA records is "Patient results may be associated with an incorrect specimen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0167-2007
Status: Terminated
Initiated: 2006-08-10
Posted: 2006-11-14
Terminated: 2016-02-22
Recalling firm: Data Innovations, LLC
Product: Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Patient results may be associated with an incorrect specimen
FDA root cause: Other
Action: Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.
Quantity in commerce: 187
Distribution: Worldwide distribution (USA and Canada)
Product codes and lots: Software Versions: 8:00, 8.01, 8.02, 8.03 or 8.04

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)