Recall Z-2427-2008 ยท GTY Antigens, All Groups, Streptococcus Spp.
Mainline Technology, Inc.
Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).
| Date | Sep 22, 2008 (initiated Nov 8, 2006) |
| Status | Terminated |
| Reason | Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were notified by phone and follow-up letter on or about 11/6/06 advising them of the problem. Consignees were give the option of returning the product and receiving the correct tip, or keeping the product and adding extra drops. Additional written notice was provide to each consignee. |
| Quantity | 11,520 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.