Data Innovations, Inc. 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Data Innovations, Inc.
Lot Codes / Batch Numbers
Software Versions: 8:00, 8.01, 8.02, 8.03 or 8.04
Products Sold
Software Versions: 8:00, 8.01, 8.02, 8.03 or 8.04
Data Innovations, Inc. is recalling Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management due to Patient results may be associated with an incorrect specimen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient results may be associated with an incorrect specimen
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026