Drug recall
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay…
FDA recall event 68230 · Class II · Alere San Diego, Inc.
Key facts
| Event ID | 68230 |
|---|---|
| Recall numbers | Z-1727-2014 |
| Recalling firm | Alere San Diego, Inc. |
| Product type | Devices |
| Products | Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected… |
| Initiation date | May 2, 2014 |
| Report date | Jun 18, 2014 |
| Termination date | Feb 27, 2015 |
| 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: