Company:Dade Behring, Inc
Date of Enforcement Report:8/29/2007
Class:ll
PRODUCT
EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007
REASON
Sample ID and Patient results could be associated with the wrong patient.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide and Belgium
Being Agile & Yet Compliant (Public)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
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Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET
IEC 62304 and other emerging standards for Medical Device and HealthIT Software
Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.
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Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
