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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.