Drug recall
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box…
FDA recall event 84698 · Class II · QUIDEL CARDIOVASCULAR INC
Key facts
| Event ID | 84698 |
|---|---|
| Recall numbers | Z-1552-2020 |
| Recalling firm | QUIDEL CARDIOVASCULAR INC |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 9, 2019 |
| Report date | Apr 1, 2020 |
| Termination date | Jan 14, 2021 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3013982035 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: