Device recall
Z-2867-2017: MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD…
FDA device recall · Class II · Sentinel CH SPA
Key facts
| Recall number (Z-number) | Z-2867-2017 |
|---|---|
| Recall event | 77405 |
| Product | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination… |
| Product code | JFY |
| Recalling firm | Sentinel CH SPA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2018 |
| 510(k) numbers | K073634 |
| FEI number | 3000303338 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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