Device recall
Z-1629-2018: ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-1629-2018 |
|---|---|
| Recall event | 79482 |
| Product | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem. |
| Product code | JKC |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 10, 2018 |
| FEI number | 3002809144 |
At a glance
- None 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