Day

August 29, 2007
Company:Dade Behring, IncDate of Enforcement Report:8/29/2007 Class:ll PRODUCT EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007 REASON Sample ID and Patient results could be associated with the wrong patient. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

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