FDA Medical Device Recalls (openFDA)
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 number
- Z-2427-2008
- Recalling firm
- Mainline Technology, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2006-11-08
- Posted
- 2008-09-22
- Terminated
- 2009-03-16
- 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.
- Lot, serial or model codes
- Lot No: 94300.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTY
- Firm FEI
- 1000160426
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28