Date Initiated by Firm |
December 22, 2006 |
Date Posted |
March 01, 2007 |
Recall Status1 |
Terminated 3 on November 28, 2007 |
Recall Number |
Z-0565-2007 |
Recall Event ID |
37234 |
510(K)Number |
K961439 K051215 K061667
|
Product Classification |
in vitro diagnostic - Product Code GIF
|
Product |
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers. |
Code Information |
Lot Number 42063I2, List Number 01H73-01 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 5440 Patrick Henry Dr Santa Clara CA 95054-1113
|
Manufacturer Reason for Recall |
Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
|
FDA Determined Cause 2 |
Other |
Action |
Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters. |
Quantity in Commerce |
652 (20 L. each) cubitainers |
Distribution |
Nationwide, including California and Nevada.
An Abbott Laboratories facility in 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 = GIF and Original Applicant = ABBOTT DIAGNOSTICS 510(K)s with Product Code = GIF and Original Applicant = ABBOTT LABORATORIES
|