Device recall
Z-0637-2013: Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative…
FDA device recall · Class III · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0637-2013 |
|---|---|
| Recall event | 63809 |
| Product | Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic… |
| 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