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U.S. Department of Health and Human Services

Class 2 Device Recall Home Strep Test

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 Class 2 Device Recall Home Strep Testsee related information
Date Initiated by FirmJuly 06, 2011
Date PostedAugust 23, 2011
Recall Status1 Terminated 3 on June 20, 2012
Recall NumberZ-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
FEI Number 3007282976
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
ActionJay 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 Commerce7,541
DistributionNationwide Distribution (USA) including the states of OR and UTAH.
Total Product Life CycleTPLC 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.
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