Date Initiated by Firm |
April 12, 2004 |
Date Posted |
April 06, 2005 |
Recall Status1 |
Terminated 3 on July 22, 2006 |
Recall Number |
Z-0673-05 |
Recall Event ID |
30922 |
510(K)Number |
K921183
|
Product Classification |
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DBM
|
Product |
Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit |
Code Information |
Software version 12 |
Recalling Firm/ Manufacturer |
Diasorin Inc. 1951 Northwestern Ave S Stillwater MN 55082-7536
|
For Additional Information Contact |
DiaSorin Technical Service 800-328-1482
|
Manufacturer Reason for Recall |
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
|
FDA Determined Cause 2 |
Other |
Action |
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed. |
Quantity in Commerce |
8 |
Distribution |
CA, CT, KS, MA & WA |
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 = DBM and Original Applicant = SHIELD DIAGNOSTICS, LTD.
|