Device recall
Z-1239-2019: AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human…
FDA device recall · Class II · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Recall number (Z-number) | Z-1239-2019 |
|---|---|
| Recall event | 82064 |
| Product | AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG). |
| Product code | JHJ |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K862044 |
| 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