Device recall
Z-0515-2019: HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture…
FDA device recall · Class II · EUROTROL INC
Key facts
| Recall number (Z-number) | Z-0515-2019 |
|---|---|
| Recall event | 81475 |
| Product | HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems. |
| Product code | GGM |
| Recalling firm | EUROTROL INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2020 |
| 510(k) numbers | K964052 |
| FEI number | 3005837764 |
At a glance
- 1–9 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