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
