Data Innovations Instrument Manager Software Cl ll

Company: Data Innovations.
Date of Enforcement Report: 9/11/2013
Class ll:

PRODUCT

1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13
2. Data Innovations Instrument Manager software Model – Versions 8.12.01
Recall Number B-2299-13

REASON
Laboratory software, with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER
1. Data Innovations, South Burlington, VT on 1/2/2013. Voluntary: Firm Initiated recall is complete
2. Data Innovations, South Burlington, VT on 9/14/2012. Voluntary: Firm Initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide and Canada

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About the author

Amy Sellers

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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Data Innovations Instrument Manager Software Cl ll

Amy Sellers

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