Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.

FDA Recall Z-1174-2007 · Posted 2007-08-22

Recalling FirmDade Behring, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2007-07-03
Date Terminated2007-11-07
Product Quantity72 units

Reason for Recall

Sample ID and Patient results could be associated with the wrong patient

Firm Action

The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.

Root Cause

Other

Distribution Pattern

Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051087DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc. · 2005-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑