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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).

FDA Recall Z-2427-2008 · Posted 2008-09-22

Recalling FirmMainline Technology, Inc.
Recall StatusTerminated
Product CodeGTY
Date Initiated2006-11-08
Date Terminated2009-03-16
Product Quantity11,520

Reason for Recall

Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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