Recall Z-3054-2011 ยท GTY Antigens, All Groups, Streptococcus Spp.
Jay Bird Investments Inc
@ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
| Date | Aug 23, 2011 (initiated Jul 6, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.