22
Nov
2006

Inc., Class II Data Innovations

0

Company:Data Innovations, Inc.,
Date of Enforcement Report:11/22/2006
Class:ll

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), Recall # Z-0167-2007

REASON
Patient results may be associated with an incorrect specimen.

CODE
Software Versions: 8:00, 8.01, 8.02, 8.03 or 8..04

RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., South Burlington, VT, by an email listserv notification and by letter dated 8/17/06. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
187 devices

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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