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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
Mainline Technology, Inc.
Lot Codes / Batch Numbers
Lot No: 94300.
Products Sold
Lot No: 94300.
Mainline Technology, Inc. is recalling Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of due to Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026