| Class 2 Device Recall PSA Test Card (Serum) | |
Date Initiated by Firm | March 04, 2014 |
Date Posted | April 07, 2014 |
Recall Status1 |
Terminated 3 on May 09, 2014 |
Recall Number | Z-1361-2014 |
Recall Event ID |
67665 |
Product | PSA Test Card (Serum);
LumiQuick.
Santa Clara, CA 95054 |
Code Information |
Catalog number: 72003, All lots |
Recalling Firm/ Manufacturer |
LumiQuick Diagnostics Inc. 2946 Scott Blvd Santa Clara CA 95054-3312
|
For Additional Information Contact | Doug Rundle 408-855-0061 |
Manufacturer Reason for Recall | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. |
FDA Determined Cause 2 | No Marketing Application |
Action | Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers. |
Quantity in Commerce | ALL |
Distribution | Distributed in the states of CA, FL, NJ, TX, and NY. |
|
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.
|
|
|
|