RecallDepth

Aqueduct Hematology Workflow Manager, software

This recall has been terminated (originally issued August 10, 2005).

Company
Beckman Coulter Inc.
Recall Initiated
August 10, 2005
Terminated
April 3, 2012
Recall Number
Z-1440-05
Quantity
36
Firm Location
Brea, CA
Official Source
View on FDA website ↗

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.

Distribution

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

Lot / Code Info

Part Number AQDCT

Root Cause

Other

Action Taken

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.

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