Device recall
Z-0762-2017: The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid…
FDA device recall · Class II · Randox Laboratories
Key facts
| Recall number (Z-number) | Z-0762-2017 |
|---|---|
| Recall event | 75262 |
| Product | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer… |
| Product code | JJY |
| Recalling firm | Randox Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2018 |
| 510(k) numbers | K110534 |
| FEI number | 1000361607 |
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