FDA Recall
Terminated
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).
Recall: Z-2427-2008
·
Initiated November 8, 2006
Recall
- Recall Number
- Z-2427-2008
- Event Number
- 49082
- Firm
- Mainline Technology, Inc.
- FEI Number
- 1000160426
- Product Code
- GTY
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- November 8, 2006
- Posted
- September 22, 2008
- Terminated
- March 16, 2009
- Address
- 3985 Research Park Dr, Ann Arbor, MI, 48108-2282
Description
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).
Reason
Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
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.
Distribution
Nationwide Distribution.
Quantity
11,520