Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococca
FDA device recall Z-2427-2008 · posted 2008-09-22 · Terminated
Recall details
- Recalling firm
- Mainline Technology, Inc.
- Reason for recall
- Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
- Action taken
- 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
- Status
- Terminated
- Product code
- GTY
- Quantity affected
- 11,520
- Distribution
- Nationwide Distribution.
- Date initiated
- 2006-11-08
- Date posted
- 2008-09-22
- Date terminated
- 2009-03-16
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.