Reported Apr 1, 2020 · Terminated
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel…
Quidel Cardiovascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QUIDEL CARDIOVASCULAR INC · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- 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
- Lot codes and dates
- Lot NumberC3470AN Part Number 94413
- Amount recalled
- 123 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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