[Recalled] 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 — Due to an error in the p
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | QUIDEL CARDIOVASCULAR INC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1552-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 April 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.