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Terminated

Aqueduct Hematology Workflow Manager, software

FDA Recall Z-1440-05 · Posted None

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2005-08-10
Date Terminated2012-04-03
Product Quantity36

Reason for Recall

Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

Firm Action

A Product corrective action letter to be mailed the week of August 8, 2005, to all customers directing that each patient is identified with a truly unique patient identifier.

Root Cause

Other

Distribution Pattern

AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA

Official Source

View FDA Recall →

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

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