Device recall
Z-0686-2013: NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product…
FDA device recall · Class II · Perkinelmer
Key facts
| Recall number (Z-number) | Z-0686-2013 |
|---|---|
| Recall event | 63771 |
| Product | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment… |
| Product code | JNB |
| Recalling firm | Perkinelmer |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2014 |
| 510(k) numbers | K021541 |
| 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