Device recall
Z-0636-2013: Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry…
FDA device recall · Class III · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0636-2013 |
|---|---|
| Recall event | 63809 |
| Product | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity… |
| Product code | JJW |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 6, 2014 |
| 510(k) numbers | K943780 |
| FEI number | 3002637618 |
At a glance
- 1–9 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