Device recall
Z-1695-2023: RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic…
FDA device recall · Class III · Mechatronics USA
Key facts
| Recall number (Z-number) | Z-1695-2023 |
|---|---|
| Recall event | 92276 |
| Product | RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578 |
| Product code | GKB |
| Recalling firm | Mechatronics USA |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3004016971 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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