FDA Medical Device Recalls (openFDA)
Jay Bird Investments Inc: @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
- Recall number
- Z-3054-2011
- Recalling firm
- Jay Bird Investments Inc
- Product
- @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
- Status
- Terminated
- Initiated
- 2011-07-06
- Posted
- 2011-08-23
- Terminated
- 2012-06-20
- Reason
- Home Strep Test does not qualify as a Class I device and needs pre-market approval.
- Root cause
- 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
- 7,541
- Distribution
- Nationwide Distribution (USA) including the states of OR and UTAH.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTY
- Firm FEI
- 3007282976
- Firm city
- Layton
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28