| Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System |  |
Date Initiated by Firm | March 02, 2010 |
Date Posted | May 26, 2010 |
Recall Status1 |
Terminated 3 on May 23, 2012 |
Recall Number | Z-1656-2010 |
Recall Event ID |
55194 |
510(K)Number | K081930 |
Product Classification |
Counter, differential cell - Product Code GKZ
|
Product | UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
|
For Additional Information Contact | 714-993-5321 |
Manufacturer Reason for Recall | Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results.
Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files.
Impact: If the last run for a control lot |
FDA Determined Cause 2 | Software design |
Action | Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form.
For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694. |
Quantity in Commerce | 63 units |
Distribution | Nationwide Distribution (AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, WA, and WI) and Canada. |
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.
|
510(K) Database | 510(K)s with Product Code = GKZ
|
|
|
|