Date Initiated by Firm |
March 19, 2001 |
Date Posted |
July 02, 2003 |
Recall Status1 |
Terminated 3 on October 03, 2006 |
Recall Number |
Z-0961-03 |
Recall Event ID |
26402 |
Product Classification |
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg - Product Code LJB
|
Product |
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055 |
Code Information |
Lot No: 00008066; Expiration Date: 08-11-2001. |
Recalling Firm/ Manufacturer |
Zeus Scientific Inc 200 Evans Way Branchburg NJ 08876
|
For Additional Information Contact |
Mr. Mark J. Kopnitsky 908-526-3744
|
Manufacturer Reason for Recall |
Mix-up between low positive and negative controls.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus. |
Quantity in Commerce |
15 kits |
Distribution |
NJ |
Total Product Life Cycle |
TPLC Device Report
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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.
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