Device recall
Z-2196-2013: DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality…
FDA device recall · Class II · Assuramed
Key facts
| Recall number (Z-number) | Z-2196-2013 |
|---|---|
| Recall event | 65980 |
| Product | DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439… |
| Product code | JJW |
| Recalling firm | Assuramed |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2017 |
| FEI number | 3009929723 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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