Device recall
Z-0688-2013: NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is…
FDA device recall · Class II · Perkinelmer
Key facts
| Recall number (Z-number) | Z-0688-2013 |
|---|---|
| Recall event | 63771 |
| Product | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. |
| Product code | JLA |
| Recalling firm | Perkinelmer |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2014 |
| 510(k) numbers | K071649 |
| FEI number | 3006159931 |
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