Device recall
Z-2586-2017: Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part…
FDA device recall · Class II · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2586-2017 |
|---|---|
| Recall event | 77003 |
| Product | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. |
| Product code | CIG |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2017 |
| 510(k) numbers | K040391 |
| FEI number | 1827821 |
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