|
Class 2 Device Recall Home Strep Test |
|
Date Initiated by Firm |
July 06, 2011 |
Date Posted |
August 23, 2011 |
Recall Status1 |
Terminated 3 on June 20, 2012 |
Recall Number |
Z-3054-2011 |
Recall Event ID |
59276 |
Product Classification |
Antigens, all groups, streptococcus spp - Product Code GTY
|
Product |
@ Home Strep Test Rapid Strep Test
Product Usage: For in-vitro diagnostic use - detection of Strep. |
Code Information |
04090001, 04090002, 05090001, 07090001, 07090002, 08090001, 08090002, 09090003, 09090001, 09090002, 10090001, 10090003, 10090002, 11090001, 12090001, 12090002, 01100001, 01100002, 02100001, 02100002, 02100004, 02100006, 02100008, 02100009, 03100002, 03100003, 03100004, 03100005, 04100001, 07100001, 08100001, 08100002, 09100001, 10100001, 10100002, 11100001, 12100001, 12100002, 01110001, 01110002, 01110003, 02110001, 02110002, 03110001, 05110001 |
Recalling Firm/ Manufacturer |
Jay Bird Investments Inc 12 S Main St STE 206 - 208 Layton UT 84041-3710
|
For Additional Information Contact |
801-721-3528
|
Manufacturer Reason for Recall |
Home Strep Test does not qualify as a Class I device and needs pre-market approval.
|
FDA Determined Cause 2 |
PMA |
Action |
Jay Bird Investments, Inc. sent a notification letter dated July 6, 2011 to customers. The letter describes the product, problem and the actions to be taken. The customers were instructed to notify retailers and remove the product from the shelves.
For questions regarding disposition of the product please contact Myron Bouwhuis at 801-721-3528. |
Quantity in Commerce |
7,541 |
Distribution |
Nationwide Distribution (USA) including the states of OR and UTAH. |
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.
|
|
|
|