Inc. ClassIII Dade Behring Marburg

Company: DADE BEHRING MARBURG
Date of Enforcement Repor: 8/22/01t
Class: III

RECALL NUMBER, PRODUCT AND CODE:
Z-0906-1, Behring Coagulation System (BCS) software version 2.2

REASON:
Leak of piston pump valve introduces air bubbles

MANUFACTURER:
DADE BEHRING MARBURG, Germany

RECALLED BY:
DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem and the name of the additional file to correct the problem.

FIRM INITIATED RECALL:
Complete

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.

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