|
Class 2 Device Recall CELLDYN 1700 Hematology Analyzer |
|
Date Initiated by Firm |
May 16, 2007 |
Date Posted |
August 18, 2007 |
Recall Status1 |
Terminated 3 on January 11, 2011 |
Recall Number |
Z-1171-2007 |
Recall Event ID |
38042 |
510(K)Number |
K870233
|
Product Classification |
Hematology Analyzer - Product Code GKZ
|
Product |
Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Abbott Laboratories Diagnostics Division |
Code Information |
ALL serial numbers. |
Recalling Firm/ Manufacturer |
Abbott Laboratories 5440 Patrick Henry Dr Santa Clara CA 95054-1113
|
For Additional Information Contact |
408-982-4800
|
Manufacturer Reason for Recall |
Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)
|
FDA Determined Cause 2 |
Other |
Action |
The firm initially sent reports (Product Information Letters) of this issue to the field on May 7, 2007. The firm sent a notice with customer notification response form on May 16, 2007 (Product Correction Letter). In addition, product information letters are being packed with the instruments accessory kit and quality control products used with the Cell-Dyn 1700 system. |
Quantity in Commerce |
4,197 units total (both models) |
Distribution |
WORLDWIDE: Product was distributed nationwide to all 50 states, as well as worldwide to Anguilla, Argentina, Australia, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Malaysia, Mexico, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela. |
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 and Original Applicant = ABBOTT DIAGNOSTICS
|
|
|
|