Quidel recalls Triage TOX Drug Screen Control 1 Kit boxes with a programming error causing false failing results for AMP and mAMP tests. Affected kits may display control failures when they don't exist.
Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.
Quidel is recalling Triage TOX Drug Screen Control 1 Kit boxes that may show false failing results for AMP and mAMP tests due to a programming error in the control chip. This could lead to incorrect test results if the control fails when it shouldn't.
The control chip in the kit has a programming error that causes the Triage Meter to show a failing control result for AMP and mAMP tests even when the control is actually working. This means the test might give incorrect results if the control fails when it shouldn't.
Users of the Quidel Triage TOX Drug Screen Control 1 Kit boxes with lot number C3470AN are affected. People testing drugs at home with this kit may see false control failures.
Check for the kit box with lot number C3470AN. The product contains 5 Control 1 vials with 5 x 0.25 mL vials per box.
Look for lot number C3470AN on the box to confirm if it's affected.
Due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.
Check the lot number on the box. If it's C3470AN, stop using it and contact Quidel for instructions.
No. The hazard is limited to false test results, not physical harm.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1552-2020 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1552-2020 from Quidel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
