Device recall
Z-2631-2017: Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS)…
FDA device recall · Class III · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2631-2017 |
|---|---|
| Recall event | 77451 |
| Product | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High… |
| Product code | DCK |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 24, 2017 |
| 510(k) numbers | K030545 |
| 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