Date Initiated by Firm |
October 26, 2004 |
Date Posted |
April 06, 2005 |
Recall Status1 |
Terminated 3 on July 22, 2006 |
Recall Number |
Z-0674-05 |
Recall Event ID |
30924 |
510(K)Number |
K982879
|
Product Classification |
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) - Product Code MSV
|
Product |
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay 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 Services 800-328 Ext. 1482
|
Manufacturer Reason for Recall |
Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications. |
Quantity in Commerce |
7 |
Distribution |
CT, MI, MT, UT & 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 = MSV and Original Applicant = SHIELD DIAGNOSTICS, LTD.
|