Date Initiated by Firm |
July 01, 2014 |
Date Posted |
July 24, 2014 |
Recall Status1 |
Terminated 3 on July 24, 2014 |
Recall Number |
Z-2113-2014 |
Recall Event ID |
68709 |
Product Classification |
Pathology Test System - Product Code MVC
|
Product |
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. |
Code Information |
Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014. |
Recalling Firm/ Manufacturer |
Biogenex Laboratories, Inc. 49026 Milmont Dr Fremont CA 94538-7301
|
For Additional Information Contact |
Ajoy Kumar Prem 510-824-1440
|
Manufacturer Reason for Recall |
Product was distributed without 510(k) approval.
|
FDA Determined Cause 2 |
No Marketing Application |
Action |
Each customer contacted by phone - neither is in possession of the product. |
Quantity in Commerce |
4 kits |
Distribution |
Brazil and Ecuador. No US distribution |
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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