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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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Partners located in the US (CA, FL, MA, MN) and Italy.