Company: Dade Behring Marburg GMBH
Date of Enforcement Report: 10/24/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer.
Codes: Software Version 2.2 Code OVIO03
REASON:
Falsely shortened APTT value.
MANUFACTURER/RECALLING FIRM:
Dade Behring Marburg GMBH, Marburg, Germany
RECALLED BY:
Dade Behring, Inc., Newark, DE, by letter on 6/25/01
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide
QUANTITY:
167
