Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error
Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software/programming error causing false failing results, which is a moderate risk of diagnostic error without reported injuries or deaths.
Plain-English summary
Quidel Cardiovascular Inc. is recalling 123 kits of the Triage TOX Drug Screen Control 1. The affected product consists of boxes containing five Control 1 vials. The recall is limited to Lot Number C3470AN and Part Number 94413.
The recall was initiated due to a programming error in the Control CODE CHIP module for this specific lot. This error causes the Triage Meter to display a failing control result for the AMP and mAMP tests, even when the control did not actually fail. This issue results in inappropriate failing results being displayed for these specific tests.
The affected kits were distributed in the United States to the states of Idaho, Florida, Georgia, Illinois, Texas, Kentucky, Missouri, Alabama, Utah, Iowa, Washington, Ohio, Arizona, New York, Oklahoma, Oregon, Indiana, and Kansas. They were also distributed to California and the Netherlands. Users should stop using the affected kits and contact Quidel for further instructions.
The recalled product
- Product
- Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
- Manufacturer
- QUIDEL CARDIOVASCULAR INC
- Affected units
- 123
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: C3470AN Part Number 94413
Distribution
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