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
