Inc Class II Dade Behring

Company: Dade Behring, Inc
Date of Enforcement Report: 8/21/02
Class: II

PRODUCT
Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry Analyzer). Recall # Z-1226-2.

REASON
The sample probe does not accurately track the fluid level.

CODE
Xpand software revision 6.0.1 and 6.1.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE, by telephone on May 11, 2002.
Manufacturer: Dade Behring, Inc., Brookfield, CT.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
261.

DISTRIBUTION
Nationwide.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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