11
Aug
2011

Cl ll ORTHO Pro Vue

0

Company: Micro Typing Systems, Inc.
Date of Enforcement Report 8/10/11
Class ll:

PRODUCT
ORTHO Pro Vue, Software Version 3.1. Upon turning the ORTHO Pro Vue on, the screen that appears immediately after the log in screen is the one that contains the Software Version. Software version is located in the upper right hand corner of the screen. Affected product would say 3.1. Recall # B-1803-11

REASON
ORTHO ProVue Analyzer Software Version 3.1, with a glitch in the software, was distributed.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Micro Typing Systems, Inc., Pompano Beach, FL, by letters and e-mail on May 27, 2010.
Manufacturer: Diagnostic Grifols, S.A., Barcelona, Spain. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
491 units

DISTRIBUTION
Nationwide, PR and Canada

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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