Z-2427-2008

Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A...

Name: Z-2427-2008 Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A...
Creator: Mainline Technology, Inc.
Published: 2006-11-08
License: https://open.fda.gov/license/

Mainline Technology, Inc. / initiated 2006-11-08 / Terminated

FDA source

Mainline Technology, Inc. began a recall of 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... on 2006-11-08. The reason FDA records is "Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2427-2008
Status: Terminated
Initiated: 2006-11-08
Posted: 2008-09-22
Terminated: 2009-03-16
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).
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
FDA 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 in commerce: 11,520
Distribution: Nationwide Distribution.
Product codes and lots: Lot No: 94300.

Product code GTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)