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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 10, 2005
Create Date June 25, 2015
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-1440-05
Recall Event ID 32931
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Aqueduct Hematology Workflow Manager, software
Code Information Part Number AQDCT
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nancy E. Johnson
714-961-4489
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 36
Distribution AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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