Sep

2012

Cl ll ORTHO-ProVue

Company:Micro Typing Systems Inc.
Date of Enforcement Report 9/19/12
Class ll:

PRODUCT

ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.B-2373-12

REASON
ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed.

RECALLING FIRM/MANUFACTURER
Capintec Inc., Pompano Beach FL on 7/8/2004. Voluntary: Firm Initiated recall has been terminated.

VOLUME OF PRODUCT IN COMMERCE
1 units

DISTRIBUTION
Nationwide and Canada

___________________________________

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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Cl ll ORTHO-ProVue

Amy Sellers

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