Company: Bayer Corp.
Date of Enforcement Report: 11/5/03
Class: II
PRODUCT
Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04.
REASON
Potential for bias shift in p02 values due to air bubble in sample path.
CODE
Software Versions below 3.1.
RECALLING FIRM/MANUFACTURER
Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
494 units.
DISTRIBUTION
Nationwide and Internationally.
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.
Lead Instructor: Mike Russell
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.
3-days onsite with group exercises, quizzes, examples, Q&A.
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Next public offering: TBD
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Registration Link:
TBD
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
