Dade Behring Marburg GMBH Marburg ClassII

Company: Dade Behring Marburg GMBH Marburg
Date of Enforcement Report: 9/12/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:

Z-0906-1
Behring Coagulation System (BCS) software
CODES:
Model OVIO03, Version 2.2

REASON:
Leak of piston pump valve introduces air bubbles.

MANUFACTURER/RECALLING FIRM:
Dade Behring Marburg GMBH Marburg

RECALLED BY:
Dade Behring, Inc., Newark, DE, by letter.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
NY, IL,and MI

QUANTITY:
3 units

About the author

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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