Device recall
Z-2116-2017: Pointe Scientific Hitachi AST Reagent R1: PE plastic bottle w/PP plastic cap…
FDA device recall · Class III · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2116-2017 |
|---|---|
| Recall event | 76985 |
| Product | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers. |
| Product code | CIT |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 2, 2017 |
| 510(k) numbers | K941132 |
| 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