Device recall
Z-2140-2018: lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and…
FDA device recall · Class III · Alere San Diego Inc. DBA Immunalysis Corporation
Key facts
| Recall number (Z-number) | Z-2140-2018 |
|---|---|
| Recall event | 80096 |
| Product | 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 cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific… |
| Product code | DJR |
| Recalling firm | Alere San Diego Inc. DBA Immunalysis Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 29, 2021 |
| 510(k) numbers | K151395 |
| FEI number | 2020952 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database