Oct

2009

Cl Il Ortho ProVue

Company:Micro Typing Systems, Inc.
Date of Enforcement Report 10/14/2009
Class:ll

PRODUCT
Ortho ProVue, Product Code MTS213784. Recall # B-1268-09

REASON
Software, with an anomaly (Versions 2.16 and below) affecting transmission of results from the Ortho ProVue using a bi-directional Laboratory Information System (LIS) interface, was distributed.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Micro Typing Systems, Inc., Pompano Beach, FL, by letters dated June 25, 2007, September 17, 2007 and November 16, 2007.
Manufacturer: Diagnostic Grifols, Parets Del Valles, Spain. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
558 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 Il Ortho ProVue

Amy Sellers

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