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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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