|
Class 2 Device Recall CELLDYN |
|
Date Initiated by Firm |
July 25, 2007 |
Date Posted |
January 04, 2008 |
Recall Status1 |
Terminated 3 on November 17, 2009 |
Recall Number |
Z-0301-2008 |
Recall Event ID |
45446 |
510(K)Number |
K051215
|
Product Classification |
Hematology Analyzer Syringe - Product Code GKZ
|
Product |
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, ) |
Code Information |
Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007 |
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 |
Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott |
Quantity in Commerce |
302 units |
Distribution |
Worldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Australia, Brazil, Chile, Germany, and Hong Kong. |
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 LABORATORIES
|
|
|
|