Z-3054-2011

@ Home Strep Test Rapid Strep Test

Name: Z-3054-2011 @ Home Strep Test Rapid Strep Test
Creator: Jay Bird Investments Inc
Published: 2011-07-06
License: https://open.fda.gov/license/

Jay Bird Investments Inc / initiated 2011-07-06 / Terminated

FDA source

Jay Bird Investments Inc began a recall of @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep on 2011-07-06. The reason FDA records is "Home Strep Test does not qualify as a Class I device and needs pre-market approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3054-2011
Status: Terminated
Initiated: 2011-07-06
Posted: 2011-08-23
Terminated: 2012-06-20
Recalling firm: Jay Bird Investments Inc
Product: @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Home Strep Test does not qualify as a Class I device and needs pre-market approval.
FDA 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 in commerce: 7,541
Distribution: Nationwide Distribution (USA) including the states of OR and UTAH.
Product codes and lots: 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

Product code GTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)