Device recall
Z-1267-2018: EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4…
FDA device recall · Class II · Medica Corporation
Key facts
| Recall number (Z-number) | Z-1267-2018 |
|---|---|
| Recall event | 77160 |
| Product | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. |
| Product code | JIT |
| Recalling firm | Medica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2019 |
| 510(k) numbers | K120497 |
| FEI number | 1220972 |
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