Company: DADE BEHRING, INC
Date of Enforcement Report: 9/5/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1
REASON:
Incorrect low results for a number of patient samples.
CODE:
Version 5.1
MANUFACTURER:
DADE BEHRING, INC., NEWARK, DE
RECALLED BY:
Manufacturer, by letter 4/9/01
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide
QUANTITY:
1696 units