Drug recall
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as…
FDA recall event 80096 · Class III · Alere San Diego Inc. DBA Immunalysis Corporation
Key facts
| Event ID | 80096 |
|---|---|
| Recall numbers | Z-2140-2018 |
| Recalling firm | Alere San Diego Inc. DBA Immunalysis Corporation |
| Product type | Devices |
| Products | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL… |
| Initiation date | Nov 28, 2017 |
| Report date | Jun 20, 2018 |
| Termination date | Jan 29, 2021 |
| City | Pomona |
| State | CA |
| Country | United States |
| FEI number | 2020952 |
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: