| Class 2 Device Recall | |
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
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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
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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 |
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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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