Drug recall
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence…
FDA recall event 62293 · Class II · Alere San Diego, Inc.
Key facts
| Event ID | 62293 |
|---|---|
| Recall numbers | Z-2039-2012 |
| Recalling firm | Alere San Diego, Inc. |
| Product type | Devices |
| Products | Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false… |
| Initiation date | May 14, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Dec 4, 2012 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 1000125596 |
At a glance
- 1–9 Products in this recall
- 1–9 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: