Device recall
Z-1220-2018: AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the…
FDA device recall · Class III · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Recall number (Z-number) | Z-1220-2018 |
|---|---|
| Recall event | 79198 |
| Product | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212 |
| Product code | JNO |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 6, 2018 |
| 510(k) numbers | K110274 |
| FEI number | 3002808498 |
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